Candemox Comp 16 mg / 12.5 mg Candesartan Cilexetil/Hydrochlorothiazide Tablets
What Candemox Comp Is And What Candemox Comp Used For
Your medicine is called Candemox Comp. Candemox comp used for high blood pressure ( hypertension ) in adult patients. It contains two active substances: candesartan cilexetil and hydrochlorothiazide. They work together to lower your blood pressure.
- Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It causes your blood vessels to relax and dilate, which helps lower your blood pressure.
- Hydrochlorothiazide is a group of medicines called diuretics ( diuretic agents). It helps your body eliminate water and salts, such as sodium, in the urine. This helps to lower your blood pressure.
Your doctor may prescribe Candemox Comp if your blood pressure is not adequately controlled on candesartan cilexetil or hydrochlorothiazide alone.
Candesartan cilexetil in combination with hydrochlorothiazide contained in Candemox Comp, may also be authorized for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What You Need To Know Before Taking Candemox Comp
Do Not Take Candemox Comp:
- If you are allergic to candesartan cilexetil, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to medicines containing sulfonamides. If you are unsure if this applies to you, talk to your doctor.
- If you have severe liver disease or biliary obstruction (a condition where bile has difficulty leaving the gallbladder).
- If you have severe kidney problems.
- If you are more than three months pregnant (even earlier in pregnancy, it is good to avoid Candemox Comp, see Pregnancy and breastfeeding).
- If you have ever had gout.
- If you have persistently low levels of potassium in your blood.
- If you have persistently high levels of calcium in your blood.
- If you have diabetes or impaired kidney function and are being treated with an antihypertensive medicine containing aliskiren.
If you are unsure if any of the above apply to you, talk to your doctor or pharmacist before taking Candemox Comp.
Warnings And Precautions
Talk to your doctor or pharmacist before taking Candemox Comp:
- If you have heart, liver, or kidney problems.
- If you have recently had a kidney transplant.
- If you vomit, have recently had severe vomiting, or have diarrhea.
- If you have a disease of the adrenal gland called Conn’s syndrome (also called primary hyperaldosteronism).
- If you have diabetes s.
- If you have ever had a disease called systemic lupus erythematosus ( SLE ).
- If you have low blood pressure.
- If you have ever had a stroke.
- If you have ever had allergies or asthma.
- If you have previously had breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you experience severe shortness of breath or problems after taking Candemox Comp, seek medical attention immediately.
- If you are taking any of the following medicines used to treat high blood pressure :
- An ACE inhibitor (eg enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.
- the aliskiren
- If you have skin cancer or get an unexpected skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sunlight and UV rays exposure while taking Candemox Comp.
- If you experience impaired vision or eye pain. These may be symptoms of fluid accumulation in the eye (between the choroid and sclera) or an increase in pressure in the eye and may occur within hours to weeks of taking Candemox Comp. Untreated, it can lead to permanent vision loss. If you have previously had a penicillin and sulfonamide allergy, you may have a higher risk of this
- if you think you are (or could become) pregnant. Candemox Comp is not recommended during early pregnancy and must not be taken after the first three months. The medicine can cause serious harm to the baby if used during that stage (see Pregnancy and breast-feeding section).
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 the information under the heading “Do not take Candemox Comp.” Your doctor may want to see you more often and take some tests if you have any of these conditions.
Tell your doctor or dentist that you are taking Candemox Comp if you are going to undergo any surgery. The reason is that Candemox Comp, in combination with certain anesthetics or anesthetics, can cause a sharp drop in blood pressure. Candemox Comp can make the skin more sensitive to sunlight.
Children And Young People
There is no experience using Candemox Comp in children and adolescents (under 18 years of age). Therefore, Candemox Comp should not be given to children and adolescents.
Other Medicines And Candemox Comp
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Candemox Comp can affect how some other medicines work, and some other medicines can affect Candemox Comp. If you are using certain medicines, your doctor may need to take blood samples from time to time.
In particular, tell your doctor if you are using any of the following medicines, as your doctor may need to change your dose and take other precautions:
- An ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candemox Comp” and “Warnings and precautions”)
- Other medicines that help lower blood pressure include beta-blockers, aliskiren-containing medicines, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
- Medicines to control the heart rhythm (antiarrhythmic agents), such as digoxin and beta blockers.
- Non-steroidal anti-inflammatory drugs ( NSAIDs ) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines that relieve pain and inflammation ).
- Acetylsalicylic acid (if you take more than 3 g a day) (a medicine that relieves pain and inflammation ).
- Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in the blood).
- Heparin (a blood-thinning medicine).
- Fluids ( diuretics ).
- Lithium (a drug for mental illness).
- Medicines that can be affected by the potassium level in the blood, such as some antipsychotic medicines.
- Medicines that lower cholesterol levels, such as colestipol or cholestyramine (resin-type fat-lowering agents).
- Calcium or vitamin D supplements.
- Anticholinergic agents such as atropine and biperiden.
- Amantadine (for Parkinson’s disease or serious viral infections).
- Barbiturates (a type of sedative also used for epilepsy ).
- Medicines against cancer.
- Steroids like prednisolone.
- Pituitary hormone (ACTH).
- Medicines for diabetes (tablets or insulin ).
- Laxatives.
- Amphotericin (for fungal infections).
- Carbenoxolone (for diseases of the esophagus or ulcers in the mouth).
- Penicillin or trimethoprim/sulfamethoxazole ( antibiotics ).
- Cyclosporine is a medicine used when transplanting organs to prevent organ rejection.
- Other medicines that may cause an increase in the blood pressure-lowering effect, such as baclofen (a medicine that relieves spasticity [muscle spasms]), amifostine (for cancer), and some antipsychotic medicines.
Candemox Comp With Food, Drink, And Alcohol
- You can take Candemox Comp with or without food.
- Once you have been prescribed Candemox Comp, discuss it with your doctor before drinking alcohol. Alcohol can make you feel weak or dizzy.
Pregnancy And Breastfeeding
Pregnancy
Contact your doctor if you think you are (or could become) pregnant during treatment. Usually, your doctor will suggest that you stop taking Candemox Comp before pregnancy or as soon as you know you are pregnant and will recommend another medicine for you instead. Candemox Comp should not be used in early pregnancy or during the last 6 months of pregnancy as it can cause serious birth defects.
Breast-feeding
Tell your doctor if you are breastfeeding or intend to breastfeed. Candemox Comp is not recommended for breastfeeding mothers. Your doctor may choose another medicine for you if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.
Driving Ability And Use Of Machinery
Some people may feel tired or dizzy while taking Candemox Comp. Do not drive or use tools or machines if this happens to you.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Candemox Comp Contains Lactose And Sodium
If you are intolerant to certain sugars, you should consult your doctor before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How To Take Candemox Comp
- Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure. You must continue to take Candemox Comp every day.
- The recommended dose of Candemox Comp is one tablet once daily.
- Swallow the tablet with a little water.
- Try to take the tablet at the same time each day. That way, it will be easier to remember to take it.
If You Have Taken Too Much Candemox Comp
If you have ingested too much medicine or, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If You Forget To Take Candemox Comp
Do not take a double dose to make up for a missed tablet. Take the next dose as normal.
If You Stop Taking Candemox Comp
If you stop taking Candemox Comp, your blood pressure may rise again. Therefore, do not stop taking Candemox Comp without first talking to your doctor.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible Candemox Comp Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them. You must know what the side effects may be. Some of the side effects of Candemox Comp are caused by candesartan cilexetil, and some are caused by hydrochlorothiazide.
Stop taking Candemox Comp and see a doctor immediately if you experience any of the following allergic reactions:
- Breathing difficulties, with or without swelling of the face, lips, tongue, and throat.
- Swelling of the face, lips, tongue, or throat may cause difficulty swallowing.
- Severe skin itching (with raised rashes).
Stop taking Candemox Comp and see a doctor immediately if you develop acute respiratory distress syndrome, a rare side effect (may affect up to 1 in 10,000 people). Signs of:
- Severe shortness of breath
- Fever
- Weakness
- Confusion
Candemox Comp can cause a decrease in white blood cells. Your resistance to infection may decrease, and you may feel tired, get an infection or have a fever. If this happens, contact your doctor. Your doctor may occasionally take blood samples to check whether Candemox Comp has affected your blood ( agranulocytosis ).
Other possible side effects are:
Common (may affect up to 1 in 10 users):
- Changed results of some blood tests:
- Decreased amount of sodium in the blood. If the reduction is severe, you may experience weakness, lack of energy, or muscle cramps.
- Increased or decreased amount of potassium in the blood, especially if you already have kidney problems or heart failure. If the change is severe, you may experience fatigue, weakness, irregular heartbeat, or tingling and numbness in the skin.
- An increased amount of cholesterol, sugar, or uric acid in the blood.
- Sugar in the urine.
- Feeling dizzy or weak.
- Headache.
- Respiratory tract infection.
Uncommon (may affect up to 1 in 100 users):
- Low blood pressure. It may make you feel weak or dizzy.
- Loss of appetite, diarrhea, constipation, stomach irritation.
- Skin rash, itchy bumpy rash ( hives ), rash due to sensitivity to sunlight.
Rare (may affect up to 1 in 1,000 users):
- Jaundice (yellowing of the skin or the whites of the eyes). If you get this, contact your doctor immediately.
- Impact on kidney function, especially if you have kidney problems or heart failure.
- Difficulty sleeping, depression, restlessness.
- Tingling or tingling in the arms or legs.
- Blurry vision for a short time.
- Abnormal heart rhythm.
- Difficulty breathing (including pneumonia and fluid in the lungs).
- Fever.
- Inflammation of the pancreas ( pancreatitis ). This causes moderate to severe pain in the stomach.
- Muscle cramps.
- Damage to blood vessels that causes red or purple dots in the skin.
- Decrease in the number of red or white blood cells or platelets. You may then notice fatigue, infection, fever, or bruising easily.
- Severe rash that develops quickly with blisters and peeling skin and possibly blisters in the mouth.
Very rare (may affect up to 1 in 10,000 users):
- Swelling of the face, lips, tongue, and throat.
- Itching.
- Pain in the back, joints, or muscles.
- Altered liver function, including inflammation of the liver ( hepatitis ). You may notice fatigue, yellowing skin and whites of the eyes, and flu-like symptoms.
- Cough.
- Nausea.
Has been reported (occurring in an unknown number of users):
- Sudden myopia.
- Decreased vision or pain in the eyes due to high pressure (possible sign of fluid accumulation in the eye (between the choroid and the sclera) or acute narrow-angle glaucoma ).
- Systemic and cutaneous lupus erythematosus (an allergic condition causing fever, joint pain, and skin rash, which may include redness, blistering, scaling, and lumps).
- Skin and lip cancer (non-melanoma skin cancer).
How To Store Candemox Comp
- Keep this medicine out of sight and reach of children.
- Use before the expiry date stated on the packaging and the can/blister after EXP. The expiration date is the last day of the specified month.
- Store at a maximum of 25 °C. Store in the original packaging. Moisture sensitive.
- Shelf life after opening the can: 3 months.
- Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents Of The Packaging And Other Information
Contents Declaration
- The active substances are candesartan cilexetil and hydrochlorothiazide .
- Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide .
- Other ingredients are lactose monohydrate, corn starch, povidone K30, carrageenan (E407), croscarmellose sodium, magnesium stearate, red iron oxide (E172), and yellow iron oxide (E172).
Appearance And Package Sizes Of The Medicine
16 mg/12.5 mg tablets :
Apricot-colored, mottled, oval, biconvex tablets scored on both sides.
The break score is not for dividing the tablet into equal doses, but only to facilitate swallowing.
- Al/Al blisters with desiccant:
- 7, 10, 14, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98, or 100 tablets.
- Al/Al-perforated single-dose blister pack with desiccant:
- 50×1 tablets.
- HDPE can be with a PP screw cap and desiccant:
- 7, 14, 21, 28, 56, 84, 98, 100, or 250 tablets.
- Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Lek Pharmaceuticals dd, Trimlini 2 D, 9220 Lendava, Slovenia