10mg / 12.5 mg tablets
lisinopril / hydrochlorothiazide
What Lisinopril / Hydrochlorothiazide STADA is and what it is used for
Lisinopril / Hydrochlorothiazide Stada contains a combination of two active substances, lisinopril and hydrochlorothiazide .
Lisinopril is a blood pressure-lowering medicine. It belongs to a group of medicines called ACE inhibitors. It works by dilating the blood vessels, which makes it easier for the blood to pass through them.
Hydrochlorothiazide is a diuretic that belongs to the group thiazides. It affects the kidneys to produce more urine, which lowers blood volume.
Lisinopril / Hydrochlorothiazide Stada is used to
- treat high blood pressure ( essential hypertension ).
Lisinopril / Hydrochlorothiazide Stada should be given to patients who have problems with blood pressure control as they only take lisinopril or hydrochlorothiazide.
Lisinopril and hydrochlorothiazide contained in Lisinopril / Hydrochlorothiazide Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Lisinopril / Hydrochlorothiazide STADA
Do not use Lisinopril / Hydrochlorothiazide STADA
- if you are allergic to lisinopril, other ACE inhibitors or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to hydrochlorothiazide or other sulphonamides (medicines belonging to the same group as hydrochlorothiazide )
- if you have previously been treated with an ACE inhibitor and have angioedema (swelling of the skin, especially of the face, mouth, tongue or throat with difficulty swallowing or breathing)
- if someone in your family has suffered from angioedema (it may be hereditary) or if you have suffered from angioedema for any reason other than the above
- if you have taken or are taking sakubitril / valsartan, a medicine used to treat a type of long-term ( chronic ) heart failure in adults, as it increases the risk of angioedema .
- if you have severe renal impairment (creatinine clearance <30 ml / min)
- if you suffer from suspended urinary excretion ( anuria )
- if you have severe hepatic impairment
- if you have diabetes or renal impairment and are being treated with blood pressure lowering medicines containing aliskiren
- during the last 6 months of pregnancy (treatment should also be avoided during early pregnancy, see section on pregnancy and lactation).
Warnings and cautions
Talk to your doctor or pharmacist before taking Lisinopril / Hydrochlorothiazide Stada, especially:
- if your blood pressure is too low. You may experience it as dizziness or fainting when you stand up
- if you are at risk of having a sharp drop in blood pressure due to a lack of salt and / or fluid, for example because you are taking diuretics, undergo dialysis , eat a low-salt diet or as a result of vomiting and diarrhea
- if you have a severe form of high blood pressure caused by kidney disease (renin-dependent hypertension )
- if you have a narrowing of the heart valves from the left ventricle of the heart, or any other obstruction affecting the blood flow from the left ventricle
- if you have a disease that causes thickening of the heart muscle ( hypertrophic cardiomyopathy )
- if you have heart failure
- if you suffer from angina (a heart disease when the blood flow through the heart is impaired)
- if you have any disease that affects the blood flow in the brain
- if you have impaired kidney function
- if you have narrowed vessels of the kidneys
- if you have recently had a kidney transplant
- if you have impaired liver function or suffer from a liver disease
- if you have elevated liver values or if you develop jaundice while being treated with Lisinopril / Hydrochlorothiazide Stada
- if you have elevated cholesterol levels and you are treated with so-called LDL apheresis
- if you have systemic lupus erythematosus ( SLE )
- if there is any change in the number of blood cells while you are being treated with Lisinopril / Hydrochlorothiazide Stada:
- if white blood cell count decreases ( leukopenia )
- if the number of red blood cells decreases ( anemia )
- if the platelet count decreases ( thrombocytopenia )
- or if there is a large decrease in the number of white blood cells of a specific type, which leads to increased susceptibility to infection and severe general symptoms (agranolocytosis)
- if you suffer from a connective tissue disease (collagenosis) that includes blood vessels ( collagen vascular disease)
- if you are taking medicines that inhibit your immune system
- if you are taking allopurinol (medicine for gout ), procainamide (medicine for irregular heartbeat) or lithium (medicine for various forms of depression) at the same time Lisinopril / Hydrochlorothiazide Stada should not be taken with lithium
- if you experience a hypersensitivity reaction ( allergic reaction ) or swelling of the skin ( angioedema ) while being treated with Lisinopril / Hydrochlorothiazide Stada
- the risk of angioedema may increase if you take any of the following medicines:
- racekadotril, a medicine used to treat diarrhea
- drugs used to prevent rejection of transplanted organs and against cancer (eg temsirolimus, sirolimus, everolimus)
- vildagliptin, a medicine used to treat diabetes
- If you are planning to have surgery then you will be anesthetized. Tell your doctor, dentist or other healthcare professional about it
- if you need dialysis with specific dialysis membranes (high flux membranes), undergo specific separation of the blood due to extremely high blood fats (apheresis) or desensitization to an allergy (eg bee or wasp). Your doctor may choose to discontinue treatment with Lisinopril / Hydrochlorothiazide Stada to prevent an allergic reaction.
- if you have diabetes
- if you have gout
- if you get a stubborn dry cough
- if you are at risk of elevated potassium levels in your blood, for example if you:
- take salt substitutes that contain potassium , diuretics that are potassium-sparing, or supplements with potassium
- if you are taking medicines that are associated with an increase in potassium levels in the blood
- if you do not get a satisfactory reduction in blood pressure due to ethnicity (especially for dark-skinned people)
- if you are taking any of the following medicines used to treat high blood pressure:
- an angiotensin II receptor blocker (ARB) (also known as sartans – for example valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems
- aliskiren
- if you have had skin cancer or if you get an unforeseen skin change during treatment. Treatment with hydrochlorothiazide , especially long-term use with high doses , may increase the risk of certain types of skin and lip cancer (non- melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Lisinopril / Hydrochlorothiazide Stada
- if you experience impaired vision or eye pain. This may be a symptom of fluid accumulation in the eye (between the choroid and retina) or an increase in pressure in the eye and may occur within hours to weeks after taking Lisinopril / Hydrochlorothiazide Stada. This can lead to permanent vision loss, if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at higher risk of developing this.
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.
See also information under the heading “Do not take Lisinopril / Hydrochlorothiazide Stada”
While taking Lisinopril / Hydrochlorothiazide Stada
If you develop any of the following symptoms, talk to your doctor immediately:
- You may feel dizzy after the first dose . A few people react to their first dose or when their dosage is increased with dizziness, lightheadedness, fainting or general malaise.
- Problems such as dry mouth , thirst, weakness, insomnia, muscle aches or cramps, palpitations, dizziness, nausea, vomiting and a decreased production of urine can be signs of disturbances in the body’s fluid or salt balance.
- Sudden swelling of the lips and face, sometimes even hands and feet, difficulty swallowing, rash and difficulty breathing, or wheezing and heavy breathing. This is a condition called angioedema . This can occur at any time during treatment. ACE inhibitors cause angioedema to a greater extent in black people than non-blacks.
- Fever, sore throat or blisters (this may be a symptom of an infection caused by a decrease in the number of white blood cells ).
- Yellowing of the skin and whites of the eyes (jaundice) which may be a sign of a liver disease.
In these cases, you should stop taking Lisinopril / Hydrochlorothiazide Stada and contact your doctor immediately. He/she can assess what measures need to be taken.
At the beginning of treatment and/or during a period when a dose is being adjusted, an increased number of controls may be necessary. You should go for these even if you feel healthy. Your doctor can determine how often you need follow-up.
If you experience a severe drop in blood pressure, lie down. If the condition does not go away, contact your doctor or nearest hospital immediately. Your doctor may prescribe treatment to raise your blood pressure.
Talk to your doctor if you often experience a drop in blood pressure or severe ones. It is important that your doctor may change the treatment.
Pregnancy
Tell your doctor if you think you are ( or planning to become ) pregnant.
Lisinopril / Hydrochlorothiazide Stada is not recommended during early pregnancy and should not be taken during the last 6 months of pregnancy as it may cause serious harm to the fetus when used at this stage (see Pregnancy and breast-feeding).
Increase in certain metabolites in the blood
The level of the following metabolites in the blood may increase due to the effects of hydrochlorothiazide:
- Cholesterol
- Triglyceride is
- Urine .
Children and young people
Lisinopril / Hydrochlorothiazide Stada should not be given to children as the safety and efficacy of the drug have not been established in children.
Other medicines and Lisinopril / Hydrochlorothiazide STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you have taken any of the following medicines, as their effect or the effect of Lisinopril / Hydrochlorothiazide Stada may be affected:
Diuretics that reduce potassium excretion (potassium-sparing diuretics such as spironolactone, triamterene, or amiloride), potassium supplements (including salt replacement), and other medications that can increase the amount of potassium in your blood e.g. trimethoprim and cotrimoxazole (trimethoprim/sulfamethoxazole) against infection caused by bacteria, cyclosporine, an immunosuppressive drug that prevents the rejection of transplanted organs; and heparin, a drug used to thin the blood to prevent blood clots).
Your doctor will evaluate your potassium levels regularly.
Other diuretics
These may have an increased blood pressure-lowering effect.
Other antihypertensive drugs or blood vessel dilators (nitrates)
These may have an increased blood pressure-lowering effect.
Aliskiren and angiotensin II receptor blockers, medicines used to treat high blood pressure.
Your doctor may need to change your dose and/or take other precautions:
If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Lisinopril/hydrochlorothiazide Stada” and “Warnings and precautions”).
Concomitant use increases the risk of hypotension (abnormally low blood pressure ), fainting, high levels of potassium in the blood, and changes in renal function (including acute renal failure ).
Drugs for depression and other mental illnesses ( tricyclic antidepressants, antipsychotic drugs), narcotic drugs, drugs for anesthesia
These may have an increased blood pressure-lowering effect.
Lithium (a drug for certain types of depression)
Increased risk of lithium poisoning. Concomitant use of Lisinopril / Hydrochlorothiazide Stada and lithium is not recommended. If this combination is still necessary, then lithium levels in the blood must be checked regularly by a doctor.
Medicines for pain and inflammation (non-steroidal anti-inflammatory drugs) including acetylsalicylic acid ( doses of 3g or more per day)
Concomitant use may reduce the blood pressure-lowering effect and may lead to an increase in potassium levels in the blood and impaired kidney function. In rare cases, acute renal failure, especially in patients already suffering from renal impairment.
Impaired diuretic and antihypertensive effect of hydrochlorothiazide .
Medicines that contain gold, such as sodium aurothiomalate, can be given to you as an injection.
Increased risk of symptoms such as redness, nausea, dizziness, and low blood pressure, which can be very serious.
Sympathomimetics (medicines that raise blood pressure )
These can have a reduced blood pressure-lowering effect.
Cholestyramine and colestipol (active substances that lower blood fats)
These can have a reduced blood pressure-lowering effect. The uptake of hydrochlorothiazide is delayed and weakened.
Blood sugar lowering drugs and insulin
These medications can cause a further drop in blood sugar which can lead to hypoglycemia.
Amphotericin B (the active substance used in medicines used to treat fungal infections), carbenoxolone (the active substance used to treat stomach ulcers ), cortisone preparations ( corticosteroids ), corticotropin (a hormone that acts on the adrenal glands), or certain laxatives
These preparations can affect the salt balance, for example, cause lowered potassium levels.
Calcium salts
May cause elevated calcium levels in the blood.
Cardiac glycosides, such as digoxin (the active substance that enhances the pumping effect of the heart)
Increased effect and side effects of the cardiac glucoside.
Muscle relaxants, such as tubocurarine (the active substance in muscle relaxants)
The muscle-relaxing effect is strengthened and prolonged.
Drugs associated with “torsades des pointes” (a serious type of heart rhythm disorder)
There is an increased risk of “torsades des pointes” at low potassium levels.
Allopurinol (the active substance in the treatment of gout )
Increased risk of acute renal failure. May also lead to an increased risk of lowering the number of white blood cells ( leukopenia ).
Ciclosporin (medicines that inhibit the immune system in connection with organ transplants)
Increases the risk of acute kidney failure and elevated potassium levels in the blood.
Lovastatin (active substance for lowering cholesterol )
May cause elevated potassium levels in the blood.
Procainamide (active substance for the treatment of irregular heartbeat), cytostatics (for the treatment of cancer), immunosuppressive drugs (to prevent rejection after an organ transplant)
May lead to an increased risk of lowering white blood cell count ( leukopenia ).
Sotalol (for the treatment of irregular heartbeat and high blood pressure )
Increased risk of arrhythmia (irregular heartbeat), caused by sotalol.
Trimethoprim and the combination trimethoprim/sulfamethoxazole (a medicine used to treat bacterial infections)
Increased risk of hyperkalemia (high levels of potassium in the blood).
Dialysis treatment
You should not take Lisinopril / Hydrochlorothiazide Stada if you are on dialysis. There is an increased risk of allergic reactions associated with the use of certain types of dialysis membranes (see section “Warnings and precautions” above).
mTOR inhibitors
Medicines most commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other medicines belonging to the group mTOR inhibitors). See section “Warnings and Precautions”.
Lisinopril / Hydrochlorothiazide STADA with food, drink and alcohol
Lisinopril / Hydrochlorothiazide Stada can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tell your doctor if you suspect you are (or might become) pregnant. Your doctor will usually suggest that you stop taking lisinopril/hydrochlorothiazide before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Lisinopril/hydrochlorothiazide should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause fetal harm.
Other appropriate treatments should usually replace Lisinopril / Hydrochlorothiazide Stada before you become pregnant.
Breast-feeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Lisinopril / Hydrochlorothiazide Stada is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breastfeed your baby, especially if your baby is newborn or born prematurely.
Driving and using machines
Like other antihypertensive drugs, Lisinopril / Hydrochlorothiazide Stada may affect your ability to drive or use machines. Temporary dizziness and fatigue may occur. This is most common at the beginning of treatment, with dose adjustments or in combination with alcohol. These effects depend on how receptive you are.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Lisinopril / Hydrochlorothiazide STADA
Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.
The recommended dose of Lisinopril / Hydrochlorothiazide Stada depends on the severity of your illness, previous blood pressure monitoring for each active substance, dosage one on previous treatments (for example with lisinopril alone), and your kidney function.
Your doctor may prescribe Lisinopril / Hydrochlorothiazide Stada 10 / 12.5 mg tablets for you unless your blood pressure is adequately controlled on 10 mg lisinopril alone.
Take Lisinopril / Hydrochlorothiazide Stead the tablet with a sufficient amount of water. You can take the tablet before, during, or after a meal.
The recommended dose is:
Adults
Take a Lisinopril / Hydrochlorothiazide Stada tablet daily. The tablet should be taken at about the same time each day.
You should not take more than four tablets of Lisinopril / Hydrochlorothiazide Stada per day.
Older
Elderly people with normal kidney function can take the same dose as adults.
Patients with renal impairment
You should not take Lisinopril / Hydrochlorothiazide Stada if you have a severe renal impairment ( creatinine clearance <30 ml/min).
If you have a moderate renal impairment ( creatinine clearance between 30 and 80 ml/min), your doctor will decide if you can take Lisinopril / Hydrochlorothiazide Stada or not. Your dose will be adjusted carefully. The appropriate dose for you depends on how your blood pressure is controlled as you are only taking lisinopril or hydrochlorothiazide.
Use for children and adolescents
Lisinopril / Hydrochlorothiazide Stada should not be used in children as safety and efficacy have not been established in this age group.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects or symptoms that you should pay attention to and take action if you are affected
- if you get swelling ( angioedema ) in the area around the larynx and / or tongue, you should contact a doctor so that they can treat you urgently .
- if you notice symptoms of jaundice (yellowing of the skin and whites of the eyes, dark urine) or loss of appetite, discontinue treatment and contact a doctor immediately
- if you get a fever, swollen lymph nodes and / or inflammation of the throat , contact a doctor immediately so that they can examine the number of white blood cells.
Some side effects may be warning signs of changes in blood count (see section 2 “Warnings and precautions”). Tell your doctor if you have any of the following warning signs of changes in your blood:
- dry mouth
- thirst
- impotence
- lack of energy ( lethargy )
- drowsiness
- restlessness
- muscle pain ( myalgia ) or muscle cramps
- muscle fatigue
- low blood pressure ( hypotension )
- low urine output ( oliguria )
- fast heartbeat ( tachycardia )
- gastrointestinal disorders, such as nausea and vomiting.
The following side effects may occur:
Common (may affect up to 1 in 10 people):
- dizziness, which usually gets better when the dose is lowered. In normal cases, the treatment does not need to be stopped
- headache
- fainting ( syncope )
- fatigue
- dry and stubborn cough, which disappears after the end of treatment
- low blood pressure ( hypotension ), including orthostatic hypotension ( blood pressure drops as you get up). Lie down if your blood pressure drops too much. If this persists, contact your doctor or nearest hospital immediately (see also section 2 “Warnings and precautions”).
- diarrhea
- vomiting
- renal impairment.
Uncommon (may affect up to 1 in 100 people):
- gout
- ant crawls ( paresthesia is)
- powerlessness ( asthenia )
- palpitation
- chest pain
- muscle cramps (painful and involuntary muscle contractions)
- muscle weakness
- nausea
- indigestion
- abdominal pain
- inflammation of the pancreas ( pancreatitis )
- dry mouth
- rash
- impotence
- Mood swings
- dizziness
- taste changes
- sleep disorders
- myocardial infarction (myocardial infarction) or stroke ( cerebrovascular event), possibly secondary to extremely low blood pressure ( hypotension ) in high-risk patients (see section 2)
- fast heart rate
- cold hands and feet (Raynaud’s syndrome)
- rinnsnuva
- itching
- high level of urea in the blood
- high level of creatinine in the blood, which may indicate impaired renal function. This usually disappears after the treatment is stopped
- altered liver values (increase in liver enzymes and liver bilirubin)
- high level of potassium in the blood ( hyperkalaemia ).
Rare (may affect up to 1 in 1,000 people):
- hypersensitivity reactions ( allergy ), angioedema (swelling of the arms, legs, face, lips, tongue, throat and larynx). If you notice any symptoms of angioedema stop taking Lisinopril / Hydrochlorothiazide Stada and contact your doctor immediately (see section 2 “Warnings and precautions”)
- symptoms which may consist of one or more of the following: fever, vasculitis ( vasculitis ), muscle pain ( myalgia ), pain or inflammation in the joints ( arthralgia , arthritis ), positive ANA test (anti-nuclear antibodies , a blood test to detect autoimmune diseases), increased rate of sedimentation of erythrocytes (a sign of inflammation in the body, detected with a blood test), increased number of white blood cells ( leukocytosis ) and eosinophilic granulocytes ( eosinophilia ), skin rash, increased photosensitivity or other skin problems.
- extremely low number of certain types of white blood cells , called granulocytes ( agranulocytosis ), which makes you more susceptible to infection . A clear association between lisinopril / hydrochlorothiazide treatment and agranulocytosis has not yet been established
- hemolytic anemia ( anemia caused by an abnormal breakdown of red blood cells )
- slight decrease in the level of hemoglobin and hematocrit ( red blood cells ), which may lead to anemia . These were frequently reported in patients with high blood pressure , but were rarely of clinical significance unless other causes of anemia were present.
- confusion
- hives ( urticaria )
- hair loss ( alopecia )
- psoriasis (a skin disease that causes red spots and inflammation of the skin)
- urine poisoning
- kidney failure
- breast augmentation in men
- excessive release of a hormone that can cause headaches, nausea and vomiting (Inadequate ADH – secretion – SIADH)
- low sodium level in the blood ( hyponatremia ).
Very rare (may affect up to 1 in 10,000 people):
- bone marrow depression (when the bone marrow cannot make enough blood cells ), which manifests itself as a low number of red blood cells ( anemia ), low platelet count ( thrombocytopenia ) and / or low white blood cell count ( leukopenia )
- low number of certain types of white blood cells called neutrophilic granulocytes ( neutropenia )
- enlarged lymph nodes
- autoimmune diseases
- low blood sugar ( hypoglycaemia )
- bronchospasm (causes difficulty breathing and wheezing)
- sinusitis ( sinusitis )
- pneumonia caused by allergies
- accumulation of white blood cells in the lungs
- swelling of the intestine
- hepatitis
- jaundice (yellowing of the skin and whites of the eyes, usually due to a liver disease). If you develop jaundice, stop taking Lisinopril / Hydrochlorothiazide Stada and contact your doctor immediately.
- liver failure
- sweating
- blisters and sores on the skin
- toxic epidermal necrolysis (a very serious skin disease, characterized by flaking of the skin)
- Stevens-Johnson syndrome (a serious skin condition with itchy pink-red skin spots)
- less urine than usual or no urine.
No known frequency (affects the unknown number of users):
- Lisinopril / Hydrochlorothiazide Stada may alter blood test results. These changes rarely have clinical significance.
- high blood sugar
- low level of potassium in the blood
- high level of cholesterol in the blood
- high levels of triglycerides are in the blood
- inflammation of the salivary glands
- aplastic anemia (when bone marrow can not make enough blood cells )
- loss of appetite
- sugar in the urine
- restlessness
- Depression
- depressive symptoms
- dizziness
- xantopsi (yellow syn)
- transient blurred vision
- impaired vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma ).
- If you suddenly get painful red eyes, contact your doctor immediately; you may need treatment to avoid permanent loss of vision
- irregular heartbeat
- Sudden redness of the face ( flush )
- vasculitis, which can lead to tissue death
- difficulty breathing, pneumonia and swelling and / or fluid accumulation in the lungs
- stomach irritation
- constipation
- photosensitivity reactions
- electrolyte imbalance (altered levels of water and salts in the blood)
- cutaneous lupus erythematosus-like reactions and activation or reactivation of cutaneous lupus erythemaosus (an autoimmune disease that causes rashes on the face and red scaly patches on the skin)
- severe allergic (anaphylactic) reactions
- kidney inflammation
- fever
- weakness
- skin and lip cancer (Non- melanoma skin cancer).
How to store Lisinopril / Hydrochlorothiazide STADA
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the blister after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substances are lisinopril 10 mg (as lisinopril dihydrate) and hydrochlorothiazide 12.5 mg per tablet.
The other ingredients are calcium hydrogen phosphate dihydrate (E341), magnesium stearate (E470b), maize starch, mannitol (E421), and colloidal anhydrous silica (E551).
What the medicine looks like and contents of the pack
Lisinopril / Hydrochlorothiazide Stada are white, round, biconvex, scored tablets marked C 10 on one side.
Lisinopril / Hydrochlorothiazide Stada is available in packs of 10, 14, 15, 20, 28, 30, 40, 50, 56,
60, 70, 80, 90, 98, 100, 200, 250, 400, 500 and 1000 tablets in PVC / PVDC / aluminum blister.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Centrafarm Services BV, Nieuwe Donk 9, NL-4879 AC Etten Leur, The Netherlands
Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary, Ireland
Sanico NV, Veedijk 59, Industrial Zone 4, B-2300 Turnhout, Belgium
STADApharm GmbH, Stadastrasse 2-18, 61118 Bad Vilbel, Germany
STADA Arzneimittel GmbH, Muthgasse 36, 1190 Vienna Austria
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark