25 mg, 50 mg, and 100 mg film-coated tablets 

Read all of this leaflet carefully before you start using 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: 
1. What Atenolol Teva is and what it is used for 
2. What you need to know before you use Atenolol Teva 
3. How to use Atenolol Teva 
4. Possible side effects 
5. How to store Atenolol Teva 
6. Package contents and other information 

1. What Atenolol Teva is and what it is used for

Atenolol Teva contains the active substance atenolol, which is a so-called heart-selective beta-blocker. This means that the drug mainly affects the heart and circulation, while other organs are affected very little. Atenolol Teva reduces the effects of heart-affecting substances (so-called stress hormones) that are formed in connection with mental tension and physical exertion. This causes the heart to beat more slowly ( heart rate decreases) and the heart to pump out less blood per minute. This lowers blood pressure and prevents the onset of angina (which is due to overexertion of the heart muscle).

Atenolol Teva is used to treat high blood pressure, angina ( angina pectoris ), to reduce the risk of heart attack, to provide regular cardiac activity, and to protect the heart during and after a heart attack.

Atenolol contained in Atenolol Teva may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Atenolol Teva

Do not use Atenolol Teva

  • if you are allergic to atenolol or any of the other ingredients of this medicine (listed in section 6)
  • if you have untreated heart failure (this usually leads to shortness of breath and swelling of the ankles)
  • if you have severe disorders of the cardiac conduction system (heart block, a condition that can be treated with pacemakers)
  • if you have a very slow or irregular heartbeat
  • if you have very low blood pressure
  • if you have poor blood circulation
  • if you have an untreated adrenal tumor ( pheochromocytoma )
  • if you have low pH in your body (metabolic acidosis )

Warnings and cautions

Talk to your doctor or pharmacist before using Atenolol Teva:

  • if you have any of the following diseases or symptoms: asthma or another lung disease, circulatory disorders, shortness of breath, swollen ankles, a special type of chest pain (Prinzmetal’s angina) or other heart problems, impaired kidney function, diabetes, thyroid disease, adrenal tumor
  • if you have had a severe allergic reaction to, for example, insect bites ( beta-blockers may aggravate allergic reactions)
  • if you are admitted to the hospital, tell your healthcare professional / doctor that you are taking Atenolol Teva, especially if you are going to have surgery

Other medicines and Atenolol Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The reason for this is that Atenolol Teva may affect or be affected by other medicines. Tell your doctor in particular if you are taking any medicine for:

  • irregular heartbeat, high blood pressure, angina, or heart failure (eg verapamil, diltiazem, clonidine, nifedipine, digitalis, adrenaline, or so-called class I antiarrhythmics )
  • pain or inflammation (so-called NSAIDs eg ibuprofen, indomethacin)
  • diabetes ( insulin or medicines for diabetes that you take by mouth, eg sulphonylureas)
  • muscle cramps (baclofen)

If you are going to be anesthetized before surgery, tell your doctor that you are using Atenolol Teva.

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.

There is a risk that the fetus is affected. Therefore, always consult a doctor before using Atenolol Teva during pregnancy.

Atenolol passes into breast milk. Therefore always consult a doctor before using Atenolol Teva during breast-feeding.

Driving and using machines

It is unlikely that Atenolol Teva will impair your ability to drive or perform precise work. However, temporary dizziness or fatigue may occur. In this case, you should refrain from driving or operating machinery.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

Atenolol Teva contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to use Atenolol Teva

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose for adults is 50-100 mg once a day.

In patients with severe renal impairment, the dose should be reduced.

Take the tablets at the same time each day.

The tablet can be divided into two equal doses.

Use for children

This medicine must not be given to children.

Use for the elderly

If you are older, your doctor may prescribe a lower dose, especially if you have impaired kidney function.

If you forget to use Atenolol Teva

Do not take a double dose to make up for a forgotten dose. If you miss a dose, wait and take the next dose at the usual time.

If you stop using Atenolol Teva

Do not stop taking the tablets without consulting your doctor, even if you are feeling well. If treatment with Atenolol Teva is to be stopped, it should be done gradually according to a doctor’s prescription.

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 Atenolol Teva if any of the following occur and contact a doctor immediately :

  • Abnormal heartbeat, dizziness, fatigue, and/or fainting. This may be a sign of heart block.
  • Shortness of breath and/or swollen ankles. This may be a sign of heart failure or worsening of existing heart failure.
  • Increased difficulty breathing in patients with asthma, e.g. wheezing or wheezing.

Other side effects that may occur:

Common (affects more than 1 patient in 100) :

  • Fatigue and muscle weakness, which can go away after a period of treatment.
  • Cold hands and feet, slow heart rate, diarrhea, nausea, stomach problems.

Uncommon (affects more than 1 user in 1,000 ): 

  • Sleep disorders.
  • Liver effects.

Rare (affects less than 1 in 1,000 people ):

  • Dizziness or fainting due to a drop in blood pressure, especially when getting up.
  • Numbness or cramps in the fingers.
  • Sweating. 
  • Headache.
  • Lack of platelets, which can manifest as small hemorrhages in the skin and mucous membranes.
  • Nightmares, hallucinations, disturbed perception of reality, depression, confusion.
  • Dry mouth.
  • Hair loss, rash, worsening of psoriasis.
  • Ant crawls.
  • Dry eyes and visual disturbances.
  • Erectile dysfunction.

Has been reported (occurs in an unknown number of users) : 

  • Constipation.
  • Lupus-like syndrome (a disease in which the immune system produces antibodies that primarily attack the skin and joints).

Talk to your doctor if you think you have any of these side effects or other problems with Atenolol Teva.

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 Atenolol Teva

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

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton and blister 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 atenolol. One tablet contains 25 mg, 50 mg, and 100 mg of atenolol respectively.
  • The other ingredients are microcrystalline cellulose, maize starch, magnesium subcarbonate, sodium lauryl sulfate, magnesium stearate, gelatin, titanium dioxide (dye E 171), hypromellose, glycerol 85%.

What the medicine looks like and the contents of the pack

Appearance:

25 mg: White, round and cupped tablet with a scoreline on one side. Diameter 6.6 mm. The tablet can be divided into two equal doses.

50 mg: White, round and cupped tablet with a scoreline and the marking “M006” on one side. Diameter 8.1 mm. The tablet can be divided into two equal doses.

100 mg: White, round and cupped tablet with a scoreline on one side. Diameter 10.1 mm. The tablet can be divided into two equal doses.

Pack sizes:

Blister pack 30, 100 or 100 x 1 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

Merckle GmbH, Ludwig-Merckle-Str. 3, Weiler, 89143 Blaubeuren, Germany

Muhammad Nadeem

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