120, 180, and 240 mg prolonged-release tablets are
verapamil hydrochloride
1. What ISOPTIN RETARD is and what it is used for
Isoptin Retard lowers blood pressure by dilating certain blood vessels so that vascular resistance decreases. Isoptin Retard also increases blood flow in the coronary arteries of the heart and thus counteracts angina ( angina pectoris ). Isoptin Retard is used for high blood pressure and angina.
What you need to know before taking ISOPTIN RETARD
Do not take Isoptin Retard
- 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).
Warnings and cautions
Those with the following conditions should consult a physician before starting treatment with Isoptin Retard :
- low blood pressure
- slow heart rate ( pulse )
- narrowing of the great carotid artery
- 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 RETARD
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Isoptin Retard should not be used with medicines containing ivabradine (used to treat certain heart problems).
Isoptin Retard may reduce the glucose-lowering effect of metformin (used to treat diabetes ).
Isoptin Retard 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 RETARD with food, drink and alcohol
Grapefruit juice may increase the effect of Isoptin Retard. In some patients, Isoptin Retard affects the effects of alcohol.
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.
There is a risk that the fetus is affected.
Isoptin Retard passes into breast milk. You should not breastfeed during treatment with Isoptin Retard.
Driving and using machines
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.
In some people, the ability to drive or use machines may be affected by treatment with Isoptin Retard.
ISOPTIN RETARD contains sodium
Isoptin Retard 120 mg contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free.
Isoptin Retard 180 mg contains 27.9 mg sodium (the main ingredient in table salt/table salt) per tablet. This corresponds to 1.4% of the highest recommended daily intake of sodium for adults.
Isoptin Retard 240 mg contains 37.1 mg sodium (the main ingredient in table salt/table salt) per tablet. This corresponds to 1.9% of the maximum recommended daily sodium intake for adults.
3. How to take ISOPTIN RETARD
Always take Isoptin Retard exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The dose should be determined by a doctor, who will tailor it individually for you.
The recommended dose for adults is 120-240 mg Isoptin Retard 1-2 times a day.
Use for children and adolescents
There are no data on the use of Isoptin Retard in children and adolescents.
If you use more ISOPTIN RETARD than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to use ISOPTIN RETARD
Do not take a double dose to make up for a forgotten dose.
If you stop using ISOPTIN RETARD
Always consult a doctor before stopping Isoptin Retard.
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 Retard and contact your 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. Tamsyn. 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 mucous membrane 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, internal anxiety, and inability to be still (extrapyramidal syndrome).Severe 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 RETARD
Prolonged-release tablet s 120 mg, 180 mg, and 240 mg blisters: Store at 25ºC.
Prolonged-release tablet 180 mg in a glass jar: No special storage instructions
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 120 mg, 180 mg, and 240 mg per prolonged-release tablet respectively.
The other ingredients are sodium alginate, microcrystalline cellulose, povidone, magnesium stearate, purified water, talc, hypromellose, Makrogol 400, Makrogol 6000, montanglycol wax.
dye in:
Isoptin Retard 120 mg: titanium dioxide (E171).
Isoptin Retard 180 mg: titanium dioxide (E171), iron oxide (E172)
Isoptin Retard 240 mg: titanium dioxide (E171), quinoline yellow (E104), indigo carmine (E132)
What the medicine looks like and contents of the pack
Isoptin Retard 120 mg: white, round, hilly prolonged-release tablet. The tablets have a diameter of 10 mm and are marked KNOLL, 120 SR
Isoptin Retard 180 mg: pink, oval prolonged-release tablet with scored and marked KNOLL / SR 180
Isoptin Retard 240 mg: yellow-green, oblong, cupped prolonged-release tablet.
The switch is not for dividing the tablet into equal doses, but only for easier swallowing.
Isoptin Retard 120 mg: 28 pcs and 98 pcs ( calendar pack )
Isoptin Retard 180 mg: 28 pcs and 98 pcs ( calendar pack and glass jar)
Isoptin Retard 240 mg: 28 pcs and 98 pcs ( calendar pack )
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