40 mg and 80 mg film-coated tablets
verapamil hydrochloride
1. What Isoptin is and what it is used for
Isoptin lowers blood pressure by dilating certain blood vessels so that vascular resistance decreases. Isoptin also increases blood flow in the coronary arteries of the heart and thus counteracts angina ( angina pectoris ). Isoptin is used for high blood pressure and angina, and as a preventive treatment after the acute phase of a heart attack to reduce the risk of a new heart attack. Isoptin is also used in an irregular heartbeat.
2. What you need to know before you use Isoptin
Do not take Isoptin
- if you are allergic to verapamil hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- in certain serious heart diseases such as heart failure or heart block (disorders of the heart’s conduction system).
- in acute myocardial infarction with concomitant slow heart activity, markedly low blood pressure or impaired left ventricular function.
- in atrial fibrillation / flutter with concomitant WPW syndrome (irregular heartbeat).
- in connection with overdose of drugs containing digitalis .
- if you are taking medicines containing ivabradine (used to treat certain heart problems).
Isoptin should also not be used as a preventive treatment after a heart attack if you have a very low heart rate, if you are also taking certain medicines for high blood pressure ( beta-blockers ) or if you are receiving verapamil intravenously.
Warnings and cautions
Those with the following conditions should consult a physician before starting treatment with Isoptin:
- low blood pressure
- slow heart rate ( pulse )
- narrowing of the great carotid artery
- salt balance disorders (especially reduced blood potassium)
- poor left ventricular function
- hepatic impairment
- renal impairment
- heart block (disorders of the cardiac conduction system)
- heart failure
- neuromuscular diseases (nerve diseases with muscle influence, eg muscle weakness).
Other medicines and Isoptin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Isoptin should not be used with medicines containing ivabradine (used to treat certain heart problems).
Isoptin may reduce the glucose-lowering effect of metformin (used to treat diabetes ).
Isoptin can affect or be affected by treatment with, among other things, certain drugs against:
- asthma (theophylline)
- blood clots (dabigatran and other direct-acting anticoagulants such as apixapan and rivaroxaban – medicines to prevent blood clots from forming)
- cancer (paclitaxel, doxorubicin)
- epilepsy ( phenytoin , phenobarbital, carbamazepine)
- heart disease (eg beta-receptor blockers , diuretics and digitoxin)
- high blood fats (so-called statins eg simvastatin , atorvastatin, lovastatin)
- infection is (rifampicin, clarithromycin, erythromycin, telithromycin)
- stomach upset (cimetidine)
- manic depressive illness (lithium)
- irregular heartbeat ( digoxin , quinidine , flecainide )
- pain ( acetylsalicylic acid )
- anxiety (buspirone)
- rejection after transplantation (cyclosporine, sirolimus, tacrolimus)
- anesthesia before surgery (inhalation anesthetics, midazolam, neuromuscular blockers)
- gout (colchicine, sulfinpyrazine)
- the herbal medicine St. John’s wort .
- high blood pressure (prazosin)
- benign prostatic hyperplasia (terazosin).
This is why treating physicians need to be aware of such concomitant medication.
Isoptin with food and drink
Grapefruit juice may increase the effect of Isoptin. In some patients, Isoptin affects the effects 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 taking this medicine.
There is a risk that the fetus is affected.
Isoptin passes into breast milk. You should not breastfeed during treatment with Isoptin.
Driving and using machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.
In some people, the ability to drive or use machines may be affected by treatment with Isoptin.
Isoptin contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.
3. How to use Isoptin
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one should be determined by a doctor, who will tailor it individually for you.
The recommended dose for adults is 240-480 mg Isoptin per day divided into 2-4 dosing times.
The recommended dose for children:
Isoptin: 4-10 mg / kg / day divided into 2-3 doses for infants. For older children, a lower dose , 3-6 mg / kg / day should be given.
If you take more Isoptin than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Isoptin
Do not take a double dose to make up for a forgotten dose.
If you stop using Isoptin
Always consult a doctor before stopping Isoptin.
If you have any further questions on the use of this product, ask your doctor or pharmacist
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Isoptin and contact a doctor immediately if you get any of the following symptoms:
• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing.
These symptoms are signs of angioedema which is a very rare side effect (affects less than 1 in 10,000 people).
Common (affects more than 1 user in 100)
Constipation, nausea. Slow pulse. Heart failure or worsening of heart failure, low blood pressure. Headache, dizziness, fatigue. Swollen ankles. Itching, hives. Feeling of heat and redness on the face.
Uncommon (affects less than 1 user in 100)
Chest pain, increased heart rate. Impact on heart rhythm, palpitations. Change in certain liver values. Impaired sexual ability. Loss of appetite. Skin rash, ant crawling, or numbness. Diarrhea, abdominal pain, muscle cramps, tremors, confusion, sleep disturbances, frequent urination.
Rare (affects less than 1 user in 1,000)
Hypersensitivity reaction. Fainting attack. Hormone changes (elevated prolactin levels). Running breasts. Vomiting. Dimsyn. Tinnitus (ringing in the ears, ringing in the ears). Heavy sweating.
Very rare (affects less than 1 user in 10,000)
Dizziness. Enlargement of the mammary glands in men. Swelling of the gums. Blocked intestinal passage (intestinal knot). Photosensitivity that causes allergic reactions. Reddening of the skin and small bleeding in the skin due to inflammation of the blood vessels. Skin and mucosal changes (sometimes severe). Muscle pain, joint pain.
Has been reported (occurs in an unknown number of users)
Hair loss. Movement disorders such as tremors, involuntary movements, muscle stiffness, inner anxiety, and inability to stand still (extrapyramidal syndrome). Serious disorders of the heart rhythm. High levels of potassium in the blood. Kidney failure.
Only in rare cases does treatment need to be stopped due to side effects. Constipation usually occurs at the beginning of treatment and can be counteracted with a high-fiber diet or a mild laxative (contact your doctor for advice).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Isoptin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after 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 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.
6. Contents of the packaging and other information
Content declaration
- The active substance is verapamil hydrochloride 40 mg and 80 mg respectively per tablet.
- The other ingredients are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, anhydrous colloidal silica, croscarmellose sodium, magnesium stearate, hypromellose, sodium lauryl sulphate, macrogol 6000, talc, the dye titanium dioxide (E 171).
What the medicine looks like and contents of the pack
40 mg white, cupped Ø 7mm, marked 40 and with tuber triangle
80 mg white, cupped Ø 9 mm marked Isoptin 80 / Knoll, with notch
The switch is not for dividing the tablet into equal doses, but only for easier swallowing.
40 mg tablets: 100 pcs (blister)
80 mg tablets: 100 pcs (blister)
Not all pack sizes may be marketed
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
BGP Products AB
Box 23033
104 35 Stockholm
Manufacturer:
AbbVie Deutschland GmbH Co. KG, Ludwigshafen, Germany
or
FAMAR AVE Anthoussa, Attiki, Greece