50 mg, 100 mg film-coated tablets
sertraline
What Sertraline Mylan is and what it is used for
The active substance in Sertraline Mylan is sertraline . Sertraline belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). These drugs are used to treat depression and/or anxiety disorders.
Sertraline Mylan can be used to treat
- depression and prevention of recurrent depression (in adults)
- social phobia (in adults)
- post-traumatic stress disorder (PTSD) (in adults)
- panic disorder (in adults)
- obsessive-compulsive disorder (OCD) (in adults, as well as children and adolescents in the age group 6-17 years).
Depression is a clinical illness with symptoms such as feeling sad, unable to sleep properly, or enjoying life as usual.
Obsessive-compulsive disorder and panic disorder are diseases that are linked to anxiety with symptoms such as constant discomfort (fixation), which means that you have to repeat different rituals (compulsion).
Post-traumatic stress disorder is a condition that can occur after a very emotionally traumatic experience, with some symptoms similar to depression and anxiety. Social phobia (social anxiety syndrome) is a disease that is linked to anxiety. The disease is characterized by feelings of intense anxiety or anguish in social situations (eg, talking to strangers, speaking in front of groups of people, eating or drinking in front of other people, or worrying about perhaps behaving embarrassingly).
Your doctor has decided that this medicine is suitable for treating your illness.
Ask your doctor if you are not sure why you have been given Sertraline Mylan.
Sertraline contained in Sertraline Mylan may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions
What you need to know before you take Sertraline Mylan
Do not take Sertraline Mylan
- if you are allergic to sertraline or any of the other ingredients of this medicine (listed in section 6).
- if you are taking or have taken medicines called monoamine oxidase inhibitors ( MAOIs ) (eg selegiline, moclobemide) or medicines similar to MAOIs (eg linezolid). If you stop taking sertraline, you must wait at least 1 week before starting treatment with an MAOI. If you stop taking an MAOI, you must wait at least 2 weeks before you can start treatment with sertraline.
- if you are taking a medicine called pimozide (a medicine for mental illness).
Warnings and cautions
Talk to your doctor or pharmacist before using Sertraline Mylan.
Not all medicines are suitable for all people. Talk to your doctor before taking Sertraline Mylan if you have or have ever had any of the following:
- Serotonergic syndrome or malignant neuroleptic syndrome (a condition that can be life-threatening). In rare cases, these syndromes may occur when you are taking certain other medicines simultaneously as sertraline (see section “Other medicines and Sertraline Mylan” below). (The symptoms of the serotonergic syndrome are described in section 4, “Possible side effects”). Your doctor has told you if you have had this before.
- Low sodium levels in the blood, as this can occur when treated with Sertraline Mylan. Also tell your doctor if you are taking certain medicines for high blood pressure, as such medicines can also change the levels of sodium in your blood.
- Take special care if you are elderly or suffer from severe dehydration (eg due to vomiting or severe diarrhea), as you may be at higher risk of getting low sodium levels in your blood (see above).
- Liver disease. Your doctor may decide that you should have a lower dose of Sertraline Mylan.
- Diabetes. Blood sugar levels may be affected due to Sertraline Mylan and your diabetes medication may need to be adjusted.
- Epilepsy or if you have had seizures in the past. If you have a seizure, contact your doctor immediately.
- Disease with mania and depression ( bipolar disorder ) or schizophrenia. If you have a manic period, contact your doctor immediately.
- Thoughts of harming yourself or committing suicide (see below “If you start to feel worse and have thoughts of harming yourself”).
- Bleeding, or if you have taken medicines that thin the blood (eg acetylsalicylic acid or warfarin ) or that may increase the risk of bleeding, or if you are pregnant (see “Pregnancy, breast-feeding and fertility”).
- If you are a child or young person under 18 years of age. Sertraline Mylan should only be given to children and adolescents aged 6-17 years if they suffer from obsessive-compulsive disorder. If you are being treated for this disease, your doctor will want to monitor you closely (see “Use in children and adolescents” below).
- If you receive electrical treatment (so-called electroconvulsive treatment, ECT).
- If you have or have had problems with increased pressure in your eyes (such as certain types of glaucoma or glaucoma ).
- If you have been told by an examination of your heart that you have an abnormal ECG ( electrocardiogram ) called an extended QT interval.
- If you have low levels of potassium or magnesium in your blood if there have been any sudden deaths or heart problems in your family if you have other heart problems or are taking medicines that affect your heart rhythm. These increase the risk of you having heart rhythm problems ( QT prolongation, Torsade de Pointes ).
Taking Sertraline Mylan may affect the results of any urine test.
Restlessness/akathisia
The use of sertraline has been linked to akathisia (painful restlessness and need to move, often unable to sit or stand still). This usually occurs during the first weeks of treatment.
Increasing the dose can be harmful to patients who develop such symptoms.
Withdrawal reactions
Reactions following discontinuation of treatment are common, especially if treatment is stopped abruptly (see section 3 “If you stop taking Sertraline Mylan” and section 4, “Possible side effects”). The risk of getting withdrawal symptoms depends on how long you have been treated, dosage, and how quickly one is reduced. In general, these symptoms are mild to moderate, but for some patients, they can be severe. The symptoms usually appear within the first few days after stopping treatment and usually disappear on their own or subside within 2 weeks. In some patients, they may sit for longer (2-3 months or more). If treatment with Sertraline Mylan is to be discontinued, dosing is recommended one is gradually reduced over several weeks or months, and you should always discuss the best way to discontinue treatment with your doctor.
If you start to feel worse and have thoughts of harming yourself
You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using antidepressants, as it takes time for this type of medicine to take effect, usually about 2 weeks, sometimes longer.
These thoughts may be common:
- if you have previously had thoughts of harming yourself or committing suicide,
- if you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.
Contact a doctor as soon as possible or go to the nearest hospital if you have thoughts of injuring yourself or committing suicide.
It can be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.
Drugs such as Sertraline Mylan ( SSRIs / SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.
Children and young people
Sertraline Mylan should not normally be used in the treatment of children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder. The risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance, and anger) is greater in people under the age of 18 when they take drugs of this type. Nevertheless, Sertraline Mylan may be prescribed by a doctor to patients under 18 years of age, if the doctor deems it appropriate. If a doctor has prescribed Sertraline Mylan to a patient under the age of 18 and you want to discuss this, contact your doctor. You should also inform your doctor if you notice any of the above symptoms or if these symptoms worsen in a person under the age of 18 taking SertralineMylan. In addition, the long-term effects of Sertraline Mylan on the growth, maturation, and development of intellect and behavior have not yet been established in this age group.
Other medicines and Sertraline Mylan
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
Some medicines may affect the effect of Sertralin Mylan, or Sertralin Mylan may reduce the effect of other medicines taken at the same time.
Taking Sertraline Mylan with the following medicines can cause serious side effects:
- drugs called monoamine oxidase inhibitors ( MAOIs ) such as moclobemide (for depression) and selegiline (for Parkinson’s disease ) and the antibiotic et linezolid. Do not use Sertraline Mylan with MAOIs.
- pimozide, a medicine for mental illness. Do not use Sertraline Mylan with pimozide.
- opioid drugs that treat acute or chronic pain (eg buprenorphine). Do not use Sertraline Mylan with opioids or opioid antagonists. These medicines can affect or be affected by Sertraline Mylan and can cause a life-threatening condition called serotonergic syndrome (for symptoms, see section 4 “Possible side effects”, talk to your doctor immediately).
Talk to your doctor or pharmacist if you are taking any of the following medicines:
- Medicines containing amphetamines (used to treat ADHD [attention deficit hyperactivity disorder], narcolepsy, and obesity).
- An herbal medicine contains St. John’s wort ( Hypericum perforatum ). The effect of St. John’s wort can be for 1-2 weeks.
- Products that contain the amino acid tryptophan.
- Medicines for migraine (eg sumatriptan).
- Blood thinners (eg warfarin, ticlopidine).
- Drugs for pain/joint inflammation (non-steroidal anti-inflammatory drugs ( NSAIDs ), eg ibuprofen, acetylsalicylic acid ).
- Metamizole, a medicine used to treat pain and fever
- Sedatives ( diazepam ).
- Diuretics ( diuretics ).
- Medicines for epilepsy ( phenytoin, phenobarbital, carbamazepine).
- Medicines to treat diabetes (tolbutamide).
- Medicines for strong stomach acid, stomach ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole rabeprazole).
- Lithium is a drug for mania and depression.
- Other antidepressants (eg amitriptyline, nortriptyline, desipramine, nefazodone, fluoxetine, fluvoxamine).
- Medicines for schizophrenia and other mental illnesses (eg perfenazine, levomepromazine, and olanzapine).
- Drugs used in anesthesia or to treat chronic, severe pain (mivacurium, suxamethonium, and opiates, such as fentanyl ).
- Medicines used for high blood pressure, chest pain or to regulate the speed and rhythm of the heart (such as flecainide, propafenone, verapamil, and diltiazem ).
- Medicines for HIV infection and hepatitis C ( protease inhibitors such as ritonavir, and telaprevir).
- Medicines for fungal infections (such as fluconazole , ketoconazole , itraconazole, posaconazole, voriconazole).
- Antibiotics (such as clarithromycin, erythromycin, and telithromycin).
- Aprepitant is a drug used to prevent nausea and vomiting after surgery or chemotherapy.
- Medicines to treat tuberculosis (rifampicin).
- Drugs that affect the rhythm of the heart (such as certain antipsychotic drugs and antibiotics ).
Sertraline Mylan with drinks and alcohol
Alcohol should be avoided when treated with Sertraline Mylan. Sertraline Mylan should not be taken with grapefruit juice, as this may increase the level of sertraline in the body.
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
The safety of sertraline in pregnant women has not been established. Sertraline should only be given to pregnant women if the doctor considers that the benefit to the mother outweighs the potential risks to the fetus.
Tell your midwife or doctor that you are using Sertraline Mylan. When drugs such as Sertraline Mylan are used during pregnancy, especially during the last three months, they may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact a midwife or doctor immediately.
Your newborn baby may also have other conditions, which usually begin in the first 24 hours after birth. Symptoms include:
- Respiratory problems
- Bluish skin or be too hot or too cold
- Blue lips
- Vomiting or can not be fed properly is very tired or can not sleep, or cries a lot
- Stiff muscles or muscle twitching
- Shaking, nervousness, or cramps
- Reinforced reflexes
- Irritability
- Low blood sugar
If your baby has any of these symptoms after birth or if you are worried about your baby’s health, contact your doctor or midwife who will be able to advise you.
If you take Sertraline Mylan at the end of your pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking Sertraline Mylan so that they can advise you on this.
Breast-feeding
There is evidence that sertraline is excreted in human breast milk. Sertraline should only be given to breastfeeding women if the doctor considers that the benefit to the mother outweighs the potential risks to the baby.
Fertility
In animal studies, it has been shown that certain drugs such as sertraline can reduce the quality of semen. In theory, this could affect fertility, but no such depressant effect of sertraline on fertility has yet been demonstrated in humans.
Driving and using machines
Psychotropic drugs such as sertraline may affect your ability to drive or use machines. Therefore, you should not drive or use machines until you know how this medicine affects your ability to perform these activities.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to take Sertraline Mylan
Always take this medicine exactly as your doctor or pharmacist has told you.
Sertraline Mylan tablets can be taken with or without food.
Take the medicine once a day, either in the morning or in the evening. The tablet can be divided into two equal doses.
You may find that this medicine has an unusual odor and/or taste. This is normal and can be minimized by taking the tablet with a glass of water, immediately after putting the tablet in your mouth.
Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults
Depression and obsessive-compulsive disorder
The recommended effective dose is 50 mg daily. Dose one can then be increased by 50 mg at a time at intervals of at least one week for several weeks. The maximum recommended dose is 200 mg daily.
Panic disorder, social phobia, and post-traumatic stress disorder
Treatment should start with 25 mg daily, then increase to 50 mg daily after one week. Dose one can then be increased by 50 mg at a time for several weeks. The maximum recommended dose is 200 mg daily.
Use for children and adolescents
Sertraline Mylan should only be given to children and adolescents aged 6-17 years who suffer from obsessive-compulsive disorder (OCD).
Obsessive-compulsive disorder:
Children 6-12 years: The recommended starting dose is 25 mg daily. After one week, the doctor may increase the dose from one to 50 mg daily. The maximum dose is 200 mg daily.
Adolescents 13-17 years: The recommended starting dose is 50 mg daily. The maximum dose is 200 mg daily.
If you have liver or kidney problems, tell your doctor and follow the instructions.
Your doctor will tell you how long to take this medicine. It depends on the nature of the disease and how well you respond to the treatment. It may take several weeks before your symptoms improve.
If you take more Sertraline Mylan than you should
If you accidentally ingest too much Sertraline Mylan, contact your doctor immediately or go to the nearest emergency room. Always bring the medicine package with the label on it, regardless of whether there is any medicine left or not.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremors, agitation, dizziness, and, in rare cases, unconsciousness.
If you forget to take Sertraline Mylan
If you forget to take a tablet, do not take the missed tablet. Take the next tablet at the right time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Sertraline Mylan
Do not stop taking Sertraline Mylan unless your doctor tells you to. Your doctor wants you to gradually reduce the dose of one of Sertraline Mylan for several weeks before you completely stop taking the medicine. If you suddenly stop taking this medicine, you may experience side effects such as dizziness, numbness, sleep problems, upset or anxiety, headache, nausea, vomiting, and tremors. If you experience any of these side effects or any other side effects when you stop taking Sertraline Mylan, talk to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nausea is the most common side effect. The degree of side effects depends on the dose and often disappears or decreases with continued treatment.
Talk to your doctor immediately :
If you experience any of the following symptoms after taking this medicine. The symptoms can be severe.
- If you get severe skin rashes with blisters (erythema multiforme) (this can affect the mouth, tongue, and genitals). It could be a sign of a disease called Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In this case, your doctor will stop the treatment.
- Allergic reactions or allergies may cause symptoms such as itching, raised skin rash ( hives ), breathing problems, wheezing, and swelling of the eyelids, face, or lips.
- If you get upset, confused, have hallucinations, coma, get diarrhea, have a body temperature above 38 ° C, high blood pressure, tremor, involuntary rhythmic muscle twitching, even in the muscles that control eye movements, enhanced reflexes, tense muscles, severe muscle stiffness, heavy sweating or fast heartbeat. This may be a symptom of serotonergic syndrome or malignant neuroleptic syndrome. In rare cases, these syndromes may occur when you are taking certain other medicines simultaneously as sertraline (see section 2 “Other medicines and Sertraline Mylan”). Your doctor may want to stop the treatment.
- If you get yellowish skin and yellowish eyes, which may indicate liver damage.
- If you experience symptoms of depression with suicidal thoughts or behavior.
- If you start to feel restless and cannot sit or stand still after starting Sertraline Mylan. Talk to your doctor if you start to feel restless.
- If you have a seizure.
- If you have a manic period (see section 2 “Warnings and precautions”).
The following adverse reactions have been observed in clinical trials in adults and post-marketing experience.
Very common (may affect more than 1 user in 10):
- Insomnia, dizziness, drowsiness, headache, diarrhea, nausea, dry mouth, missed ejaculation, fatigue.
Common (may affect up to 1 in 10 people):
- Tracheal catarrh, runny nose, sore throat
- Decreased or increased appetite
- Depression *, feeling strange, nightmares, anxiety *, agitation *, anxiety, decreased sexual interest *, gnashing of teeth *
- Numbness and tingling *, tremors, effects on the muscles (such as overactivity, muscle tension, difficulty walking and stiffness, spasms and involuntary movements), muscle stretching *, abnormal taste, lack of attention
- Visual disturbances *
- Earrings *
- Heartbeat *
- Hot flashes *
- Yawning *
- Stomach ache *, vomiting *, constipation *, upset stomach such as indigestion or heartburn, gas
- Rash *, increased sweating
- Muscle or joint pain *, back pain
- Potency problems, chest pain *
- Irregular human *
- Feeling sick *, fever *, weakness *
- Weight gain *
- Damage
Uncommon side effects ( may affect up to 1 in 100 people):
- Gastroenteritis, ear infection
- Tumor
- Hypersensitivity *, seasonal allergy *
- Low levels of thyroid hormone *
- Suicidal thoughts, suicidal ideation, hallucinations * (seeing, hearing, or feeling things that do not exist), euphoria * (strong happiness), indifference, abnormal thoughts, aggression *, psychotic disorder *, paranoia (a morbid state of excessive suspicion)
- Involuntary muscle contractions *, abnormal coordination, inability to be still *, memory loss, decreased emotions *, difficulty speaking, dizziness when standing up *, fainting, migraines, cramps *
- Enlarged pupils * _
- Ear pain
- Fast heartbeat *, heart problems
- Problems with bleeding (eg stomach bleeding) *, hypertension (high blood pressure ), reddening of the skin, blood in the urine
- Shortness of breath *, nosebleeds *, difficulty breathing (possibly with wheezing)
- Tar-like stools, dental problems, inflammation of the esophagus, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching
- Dark purple spots on the skin *, swelling of the face or the area around the eyes *, hair loss *, cold sweats, dry skin, itchy skin *, hives *, eczema-like skin rash ( dermatitis )
- Inflammation of joints and bones, muscle weakness, muscle cramps *, muscle twitching
- Need to urinate at night, increased urine output, need to urinate more often, difficulty urinating, urinary incontinence *
- Sexual problems, prolonged menstruation and heavy menstrual bleeding ( menorrhagia ), vaginal bleeding, sexual problems in women
- Swelling of arms and legs *, difficulty walking *, thirst, chills
- Elevated liver enzyme levels *, weight loss *
- Cases of suicidal ideation and behavior have been reported during treatment with sertraline or early after discontinuation of treatment (see section 2)
Rare (may affect up to 1 in 1,000 people):
- Inflammation of the abdomen ( diverticulitis ), swollen lymph nodes, decreased number of white blood cells *, which helps to fight infection (you can get several infections, such as sore throat, cold sores, and fever), decreased number of platelets * (you may get bruised or bleed more easily)
- Severe allergic reaction *
- Hormonal (endocrine) disorders *
- High cholesterol, low blood salts * ( sodium ), increased blood sugar level * ( hyperglycemia ), low blood sugar, problems with controlling blood sugar level ( diabetes )
- Physical symptoms due to stress or emotion *, drug dependence, sleep deprivation, premature ejaculation, nightmares *
- Coma *, abnormal movements, difficulty moving, increased sensation, disturbed sensation sudden headache (which may be a sign of a serious condition called reversible cerebral vasoconstriction syndrome) *
- Spots in front of the eyes, glaucoma (increased pressure in the eyes), double vision, light sticking in the eyes, eye bleeding *, different sized pupils *, visual impairment *, problems with tear flow
- Heart attack *, dizziness, fainting, or chest discomfort which may be signs of changes in the electrical activity of the heart (seen on ECG ) or abnormal heart rhythm *, slow heartbeat
- Poor circulation in arms and legs
- Rapid breathing, increasing scarring of the lung tissue (interstitial lung disease) *, feeling of tightness in the throat, difficulty speaking, slow breathing, hiccups
- Pain in the mouth, sores on the tongue, cold sores, inflammation of the pancreas *, blood in the stool (hematochezia)
- Problems with liver function, severe effects on liver function *, yellowing of the skin and eyes (jaundice)
- Rash on the scalp, abnormal hair structure, abnormal skin odor, bone disease, skin reactions to the sun *, skin edema *
- If you develop severe muscle pain, weakness, and muscle cramps (this is due to muscle breakdown which is called rhabdomyolysis )
- Difficulty urinating, decreased urine output
- Dry vagina, redness, and pain in the penis and foreskin *, abdominal discharge, prolonged erection, discharge from the breasts *, breast augmentation *
- Hernia, decreased drug tolerance
- Increased blood cholesterol levels *, abnormal laboratory values *, abnormal semen, problems with coagulation a *
- Vascular dilation operation
No known frequency (can not be calculated from the available data)
- Locked jaw (trismus)
- Bedwetting
- Partial loss of vision
- Severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see “Pregnancy, breast-feeding and fertility” in section 2 for more information.
- Inflammation of the colon (which causes diarrhea)
* Adverse reaction reported after marketing
Additional side effects are in children and adolescents
In clinical trials in children and adolescents, similar side effects were generally seen as in adults (see above). Following the marketing of sertraline, bedwetting has also been reported. The most common side effects in children and adolescents were headaches, insomnia, diarrhea, and nausea.
Symptoms that may occur when treatment is stopped
If you suddenly stop taking this medicine, you may experience side effects such as dizziness, numbness, sleep disturbances, upset or anxiety, headache, nausea, vomiting, and tremors (see section 3 “If you stop taking Sertraline Mylan”).
An increased risk of bone fractures has been observed in patients taking this type of medicine.
How to store Sertraline Mylan
Keep this medicine out of the sight and reach of children.
Store in the original package.
Do not use this medicine after the expiry date which is stated on the carton 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 packaging and other information
Content declaration
- The active substance is sertraline (in the form of sertraline hydrochloride). One tablet contains 50 mg or 100 mg of sertraline.
- The other ingredients are calcium hydrogen phosphate, microcrystalline cellulose, magnesium stearate sodium starch glycolate (type A), hypromellose (E 464), titanium dioxide (E 171), polydextrose (E 1200), triacetin, and macrogol.
What the medicine looks like and the contents of the pack
The appearance of the drug
50 mg tablets: white or off-white, capsule-shaped, film-coated tablet, marked on one side with “ST” and “50” on separate sides of the notch and the other with “G”. The tablet can be halved.
100 mg tablets: white or off-white, capsule-shaped, film-coated tablet, marked on one side with “ST” and “100” on separate sides of the break and the other with “G”. The tablet can be halved.
Pack sizes
HDPE cans and blisters with: 14, 15, 20, 28, 30, 50, 60, 98, 100, 250, 300 and 500 tablets.
Eventually, all pack sizes will be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
McDermott Laboratories Ltd. t / a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft., H ‑ 2900 Komárom, Mylan utca 1, Hungary