40 mg film-coated tablets
verapamil
What Verapamil Mylan is and what it is used for
Verapamil Mylan lowers blood pressure by widening certain blood vessels so that vascular resistance decreases. Verapamil Mylan also increases the blood flow in the coronary arteries of the heart and thus counteracts angina pectoris. Verapamil Mylan is used for high blood pressure and angina pectoris and as a preventive treatment after the acute phase of a heart attack to reduce the risk of a new heart attack occurring. Verapamil Mylan is also used for irregular heart activity.
The verapamil contained in Verapamil Mylan may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Verapamil Mylan
Do not take Verapamil Mylan
- if you are allergic to verapamil hydrochloride or any other ingredient in this medicine.
- in certain serious heart diseases such as heart failure or heart block (disorders in the conduction system of the heart),
- in case of acute heart attack with simultaneous slow heart activity, markedly low blood pressure, or reduced left ventricular function.
- in atrial fibrillation/flutter with an irregular heartbeat (WPW)
- in connection with the overdose of drugs containing digitalis.
- if you are already using a medicine containing ivabradine to treat certain heart diseases.
Verapamil Mylan should also not be used as a preventive treatment after a heart attack if you have a very low heart rate, if you are simultaneously taking certain medicines for high blood pressure ( beta blockers ) or if you are receiving verapamil intravenously.
Warnings and precautions
Those with the following diseases should consult a doctor before starting treatment with Verapamil Mylan
- low blood pressure
- slow heart rate ( pulse )
- narrowing of the large carotid artery
- disturbances in the salt balance (especially reduced potassium content in the blood)
- poor left ventricular function
- impaired liver function
- impaired kidney function
- heart block (disorders in the conduction system of the heart)
- heart failure
- neuromuscular diseases (nerve diseases affecting muscles, e.g. muscle weakness).
Other medicines and Verapamil Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Verapamil Mylan should not be used together with medicines containing ivabradine (used to treat certain heart problems).
Verapamil Mylan may reduce the glucose-lowering effect of metformin (used to treat diabetes ).
Verapamil Mylan can affect or be affected by treatment with, among other things, certain medicines against:
- blood clots (dabigatran and other direct-acting anticoagulants such as apixaban and rivaroxaban – medicines used to prevent blood clots from forming)
- asthma (theophylline)
- cancer (paclitaxel, doxorubicin)
- epilepsy ( phenytoin, phenobarbital, carbamazepine)
- heart disease (eg beta-blockers, diuretics, and digitoxin)
- high blood fats (so-called statins e.g. simvastatin, atorvastatin, lovastatin)
- infection (rifampicin, clarithromycin, erythromycin, telithromycin)
- stomach upset (cimetidine)
- manic depressive disorder (lithium)
- irregular heart rhythm ( digoxin, quinidine, flecainide )
- pain ( acetylsalicylic acid )
- anxiety (buspirone)
- rejection after transplantation (ciclosporin, sirolimus, tacrolimus)
- anesthesia before surgery (inhalation anesthetics, midazolam, neuromuscular blockers)
- gout (colchicine, sulfinpyrazone)
- the natural remedy St. John’s wort
- high blood pressure (prazosin)
- benign prostatic hyperplasia (terazosin).
This is why attending physicians need to be aware of such concomitant medication.
Verapamil Mylan with food and drink
Grapefruit juice may increase the effect of Verapamil Mylan. In some patients, Verapamil Mylan affects the effect of alcohol.
Pregnancy and breastfeeding
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 using this medicine.
There is a risk that the fetus will be affected.
Verapamil Mylan passes into breast milk. You should not breastfeed during treatment with Verapamil Mylan.
Driving ability and use of machinery
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. 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.
In some people, the ability to drive or use machines may be affected during treatment with Verapamil Mylan.
Verapamil Mylan contains lactose and sodium
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to take Verapamil Mylan
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure. The dose must be determined by a doctor, who will adjust it individually for you.
The recommended dose for adults is 240-480 mg per day divided into 2-4 dosing occasions.
Use for children and adolescents
Verapamil Mylan: 4-10 mg/kg/day divided into 2-3 doses for infants. For older children, a lower dose of 3-6 mg/kg/day should be given.
If you have taken too much Verapamil Mylan
If you have ingested too much medicine or if, 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 Verapamil Mylan
Do not take a double dose to make up for a missed dose.
If you stop using Verapamil Mylan
Always consult a doctor before you stop taking Verapamil Mylan.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Verapamil Mylan and contact your doctor immediately if you experience any of the following symptoms:
• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and breathing difficulties.
These symptoms are signs of angioedema which is a very rare side effect (affects less than 1 in 10,000 users).
Common (affects more than 1 in 100 users)
Constipation, nausea. Slow pulse. Heart failure or worsening of heart failure, low blood pressure. Headache, dizziness, fatigue. Swollen ankles. Itching, hives. Feeling of warmth and redness in the face.
Uncommon (affects less than 1 in 100 users)
Pain in the chest, increased pulse. Effect on heart rhythm, palpitations. Change in certain liver values. Impaired sexual ability. Loss of appetite. Skin rash, hives, or numbness. Diarrhea, stomach pains, muscle cramps, tremors, confusion, sleep disturbances, frequent urination.
Rare (affects less than 1 in 1,000 users)
Hypersensitivity reaction. Fainting attack. Hormonal changes (elevated prolactin levels). Flowing breasts. Vomiting. Blurred vision. Tinnitus (ringing in the ears). Heavy sweating.
Very rare (affects less than 1 in 10,000 users)
Dizziness. Enlargement of the mammary glands in men. Swelling of the gums. Blocked intestinal passage (colitis). Light sensitivity causes allergic reactions. Skin redness and small bleeding in the skin due to inflammation of the blood vessels. Skin and mucous membrane changes (sometimes serious). Muscle pain, joint pain.
Has been reported (occurring in an unknown number of users)
Hair loss. Movement disorders such as tremors, involuntary movements, muscle stiffness, inner restlessness, and inabi5.
le to be still (extrapyramidal syndrome). Serious disturbances in the rhythm of the heart. High levels of potassium in the blood. Kidney failure.
Only in rare cases does the treatment need to be interrupted due to side effects. Constipation usually occurs at the beginning of treatment and can be countered with a high-fiber diet or a mild laxative (contact your doctor for advice).
How to store Verapamil Mylan
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the 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 substance is verapamil hydrochloride 40 mg per tablet.
– Other ingredients are anhydrous lactose 31mg, microcrystalline cellulose, sodium starch glycolate, pregelatinized starch, talc, magnesium stearate, hypromellose, carnauba wax, diethyl phthalate, macrogol and dye titanium dioxide (E 171).
Appearance and package sizes of the medicine
Biconvex, white, diameter 7 mm marked VL/40 and G.
Plastic jar 100 and 250 tablets: Only for dose dispensing/hospital use.
Blister pack 100 x1 (single dose)
Marketing authorization holder/Information provided by:
Mylan AB Box 23033, 104 35 Stockholm
Manufacturer: Gerard Laboratories, Dublin, Ireland