25 mg, 50 mg, 100 mg tablets of
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, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
- 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. See section 4.
In this leaflet:
1. What Atenolol Orifarm is and what it is used for
2. What you need to know before you use Atenolol Orifarm
3. How to use Atenolol Orifarm
4. Possible side effects
5. How to store Atenolol Orifarm 6. Contents of the pack
and other information
1. What Atenolol Orifarm is and what it is used for
Atenolol Orifarm is a so-called selective beta-blocker. Atenolol Orifarm works by reducing the effects of heart-affecting substances (so-called stress hormones) that are formed in connection with mental tension and physical exertion. Atenolol Orifarm has a particular effect on the heart and circulation, while other organs are very little affected. The heart is affected in such a way that it beats more slowly and pumps out less blood per minute. This means that blood pressure is lowered and the number of angina attacks (angina in the heart) is reduced.
Atenolol Orifarm is used for treating high blood pressure, angina pectoris ( angina ), and irregular heartbeat.
Atenolol contained in Atenolol Orifarm 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 you use Atenolol Orifarm
Do not take Atenolol Orifarm:
- 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 or heart block (a disorder of the cardiac conduction system)
- if you have very slow or irregular heart activity of a particular type (“sick sinus node”)
- if you have very low blood pressure
- if you have poor blood circulation
- if you have an untreated adrenal tumor
- if you have been fasting for several days
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Atenolol Orifarm:
- if you have asthma or another lung disease
- if you have heart or blood circulation problems
- if you have shortness of breath
- if you have swollen ankles
- if you have a specific type of chest pain called Prinzmetal’s angina
- if you have diabetes
- if you have kidney disease
- if you have a thyroid disease
- if you have had a severe allergic reaction to, for example, insect bites ( beta-blockers may intensify allergic reactions)
If you have diabetes, you should be aware that Atenolol Orifarm may slow down the increase in heart rate that normally accompanies low blood sugar.
Atenolol slows the heart rate. This is normal, but if you are worried, talk to your doctor.
Never stop treatment without consulting your doctor. If treatment is to be stopped, this should be done gradually according to the doctor’s prescription.
If you are admitted to the hospital, tell your healthcare provider that you are taking atenolol (especially your anesthetist if you are going to have surgery).
Other medicines and Atenolol Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Atenolol Orifarm may affect or be affected by other medicines.
In particular, tell your doctor if you are taking any of the following medicines:
- Verapamil (used for diseases of the heart and vascular )
- barbituric acid derivatives (eg certain hypnotic and anti-epileptic drugs ).
- Medicines for diseases of the heart and vascular (eg agent containing diltiazem, disopyramide, class I antiarrhythmics, clonidine ),
- certain decongestants (eg agents containing phenylpropanolamine),
- certain medicines for fever, pain, and inflammation ( NSAIDs, such as indomethacin)
- adrenaline ( epinephrine ) (a drug that stimulates the heart).
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.
Atenolol Orifarm passes into breast milk but is unlikely to affect breastfed infants. However, consult a physician when using Atenolol Orifarm during breast-feeding.
Driving and using machines
Side effects are such as Fatigue has been reported during treatment with Atenolol Orifarm and may impair the ability to drive or perform precision work. It is therefore important that you know how you react to Atenolol Orifarm before you e.g. drive a car.
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.
How to use Atenolol Orifarm
Always take 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 usual dose for adults is 1 tablet (50 or 100 mg) per day.
If treatment with Atenolol Orifarm is to be stopped, this should be done gradually over 7-10 days. However, do not stop taking Atenolol Orifarm without consulting a doctor.
If you forget to take Atenolol Orifarm
Take the tablets at the same time each day. Do not take a double dose to make up for a forgotten dose. Wait and take the next dose at the normal time.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common ( may affect up to 1 in 10 people): Slow heart rate, cold hands, and feet, fatigue or muscle weakness, stomach upset (nausea, diarrhea).
Uncommon (may affect up to 1 in 100 people ): Sleep disorders, hepatic impairment.
Rare (may affect up to 1 in 1,000 people): Dizziness, especially when getting up; shortness of breath and/or swollen ankles in heart failure patients, heart block (abnormal heartbeat, dizziness, fatigue, fainting), impaired blood circulation, numbness or cramps in the fingers followed by feeling hot or in pain. Depression, nightmares, confusion and hallucinations, mental disorders. Hair loss, skin rash – also aggravated psoriasis, purple spots on the skin. Dry mouth. Decreased platelet count( thrombocytopenia ). An ant crawls in the fingers. Dry eyes, visual disturbances, increased sweating, headache, increased breathing difficulties in patients with asthma. Liver damage. Erectile dysfunction.
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 Orifarm
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 after EXP. date / 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
- The active substance is atenolol 25 mg, 50 mg, and 100 mg respectively per tablet.
- The other ingredients are sodium lauryl sulfate, magnesium stearate, gelatin, microcrystalline cellulose, talc, corn starch, and heavy magnesium subcarbonate.
What the medicine looks like and the contents of the pack
Atenolol Orifarm 25 mg, 50 mg, and 100 mg tablets are white, round, flat with a notch, diameter 8 mm, 10 mm and 12 mm respectively.
28 tablets, 30 tablets, 98 tablets, 100 tablets, 100 tablets in a plastic jar.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
5260 Odense S
Orifarm Generics AB
102 17 Stockholm