Bayer

Prolonged-release tablet 20 mg 
(round, convex, pink with a laser hole on one side, marked Adalat 20, diameter 8.4 mm)

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Adalat Oros is and what it is used for 
2. What you need to know before you use Adalat Oros 
3. How to use Adalat Oros 
4. Possible side effects 
5. How to store Adalat Oros 
6. Contents of the packaging and other information 

1. What Adalat Oros is and what it is used for

Adalat Oros is used for treating high blood pressure and stable angina in the heart.

High blood pressure occurs i.a. a. when the resistance in the blood vessels is too high. Adalat Oros is a calcium channel blocker (a drug that inhibits the influx of calcium into certain cells). Treatment with Adalat Oros reduces the tension in the muscle cells of the blood vessels. As a result, more blood (and thus more oxygen) can emerge and the blood vessels dilate. 
The most common type of angina occurs when the heart muscle receives too little oxygen. In the case of angina, Adalat Oros dilates the blood vessels, the heart does not have to work as hard to pump out the blood and thus less oxygen is needed.

Adalat Oros is a new type of tablet ( prolonged-release tablets ) of nifedipine. The drug is released continuously and gives an even effect throughout the day with a tablet once a day.

What you need to know before you use Adalat Oros

Do not use Adalat Oros

  • if you are allergic to nifedipine or any of the other ingredients of this medicine (listed in section 6)
  • if you are before week 20 of pregnancy or if you are breast-feeding
  • if you have untreated heart failure or acute myocardial infarction. Adalat Oros should not be used for the first 8 days after a heart attack
  • if you have cardiovascular shock
  • if you are being treated with rifampicin at the same time
  • if you have a so-called Kocks bladder ( ileostomy after a proctocolectomy).

Warnings and cautions

Those with the following conditions should consult a physician before starting treatment with Adalat Oros:

  • narrowing of the great carotid artery (aortic stenosis)
  • very low blood pressure
  • hepatic impairment
  • heart failure
  • narrowing of the gastrointestinal tract
  • chronic diarrhea ( Crohn’s disease, ulcerative colitis )

During X-ray examinations with contrast media, doctors should be informed about the use of Adalat Oros as the tablets may cause filling defects in the contrast which may be misinterpreted as polyps.

Children and young people

Adalat Oros is not recommended for use in children and adolescents below 18 years of age due to limited safety and efficacy data in this patient group.

Other medicines and Adalat Oros

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Also over-the-counter medicines, herbal remedies, or other natural products.

Adalat Oros is broken down via an enzyme system called cytochrome P450 3A4. Concomitant use of Adalat Oros and other medicines that affect this enzyme system may affect the effectiveness of the treatment.

Adalat Oros may affect or be affected by certain medicines containing the following active substances:

  • rifampicin (for tuberculosis )
  • cimetidine (for stomach ulcers )
  • phenytoin, carbamazepine, phenobarbital, valproic acid (for epilepsy )
  • macrolide antibiotics (eg erythromycin, clarithromycin, telithromycin) (against infections )
  • azole antifungals (eg ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole ) ( antifungal )
  • HIV – protease inhibitors (e.g., ritonavir, indinavir, saquinavir, atazanavir, nelfinavir) (to treat HIV )
  • cisapride (an intestinal stimulant)
  • fluoxetine, nefazodone, St. John’s wort (for depression)
  • quinupristin/dalfopristin (against infection )
  • verapamil, diltiazem (for high blood pressure, angina)
  • digoxin (affects heart and blood vessels)
  • quinidine (for irregular heartbeat)
  • tacrolimus (usually given after organ transplantation)
  • aprepitant (for nausea associated with chemotherapy )

Concomitant treatment with beta-receptor blockers or other antihypertensive drugs may lead to worsening of heart failure and potentiating the effect of lowering blood pressure.

Adalat Oros with food and drink

Do not drink grapefruit juice while taking Adalat Oros. It may affect the effectiveness of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnant women should not use Adalat Oros during the first 20 weeks of pregnancy. Taking Adalat Oros should be avoided by women who are planning to become pregnant or are pregnant. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.

Adalat passes into breast milk. Therefore, do not use Adalat Oros during breast-feeding unless specifically prescribed by a doctor.

Driving and using machines

Reactions to the drug can affect the ability to drive or perform precision work, especially at the beginning of treatment, when changing drugs and in combination with alcohol.

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.

Adalat Oros contains sodium

This medicine contains sodium (the main ingredient in table salt/table salt) in the following amounts: 8.3 mg (20 mg tablet), 9.4 mg (30 mg tablet), and 18.8 mg

(60 mg tablet). Increasing the daily dose to 120 mg nifedipine results in an intake of up to 37.6 mg sodium. This corresponds to 1.88% of the WHO’s highest recommended daily intake (2 grams of sodium for adults).

3. How to use Adalat Oros

Dose one is determined by the doctor, who adjusts it individually for you

In the case of angina: The appropriate starting dose is 1 tablet 30 mg once daily. Doseone may sometimes need to be increased to 60-90 mg daily. 
In the case of high blood pressure: The appropriate starting dose is 20 mg once daily. The usual maintenance dose is 20-30 mg once daily. Dose one can be increased to 60 mg once daily if needed.

The tablets must be swallowed whole with liquid and must not be crushed, chewed, or divided. 
The tablets can be taken regardless of the meal.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

Stop taking Adalat Oros and contact a doctor immediately if you get any of the following symptoms ( angioedema ):

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing

Angioedema is classified as a less common side effect, which means that less than 1 person in 100 is affected.

Adalat Oros can in rare cases affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication. The frequency of agranulocytosis is unknown.

Most side effects of Adalat Oros are related to the vasodilating effect. They usually appear at the beginning of treatment and often disappear on their own.

Common: (more than 1 person in 100 affected) Swelling, headache, flushing with a feeling of heat, constipation, general malaise.
Uncommon:(less than 1 person in 100 affected) Allergic reaction, anxiety reactions, sleep disturbances, dizziness, migraine, tremors, visual disturbances, increased heart rate, palpitations, low blood pressure, fainting spells, nosebleeds, nasal congestion, abdominal pain, nausea, indigestion, flatulence, dry mouth, dry mouth, rash increased need for urination, urination problems, erectile dysfunction, non-specific pain, chills.
Rare: (less than 1 person in 1000 affected) Itching , runny nose, rash, sensory disturbances / hallucinations, gum growth (gingival hyperplasia ).
No known frequency (cannot be calculated from the available data) Rapid onset of severe hypersensitivity reaction, elevated blood sugar, numbness, sleepiness, eye pain, chest pain ( angina pectoris ), shortness of breath, bezoars (lumps the nondegradable tablet shells in the stomach), swallowing, intestine, intestinal ulcer, vomiting, gastroesophageal sfinkterinsufficiens causing leakage of stomach acid via the upper stomach mouth this can cause heartburn, jaundice, severe widespread skin damage (skin detachment), allergic reaction with photosensitivity, reddish skin changes (purpura), joint and muscle pain.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Adalat Oros

Store in the original package. Moisture sensitive. 
Do not use this medicine after the expiry date which is stated on the carton.

Keep this medicine out of the sight and reach of children.

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 Nifedipine. One tablet contains 20 mg, 30 mg, and 60 mg nifedipine respectively. 
The other ingredients are Iron oxide, magnesium stearate, sodium chloride, hypromellose, cellulose acetate, polyethylene glycol, polyethylene oxide, hydroxypropyl cellulose, titanium dioxide, and propylene glycol.

What the medicine looks like and the contents of the pack

Round, convex, pink prolonged-release tablets with laser holes on one side, marked with ‘Adalat 20’, ‘Adalat 30’, and ‘Adalat 60’ respectively. 
All strengths have blister packs of 28 pcs and 98 pcs and a single-dose pack of 49 pcs (49×1).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bayer AB

Box 606 

SE-169 26 Solna 

Manufacturer

Bayer AG

51368 Leverkusen

Germany

Muhammad Nadeem

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