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

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.

This leaflet contains information about: 
1. What Atenolol Actavis is and what it is used for 
2. What you need to know before you use Atenolol Actavis 
3. How to use Atenolol Actavis 
4. Possible side effects 
5. How to store Atenolol Actavis 6. Contents of the pack 
and other information 

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

Atenolol Actavis contains the medicine atenolol. It belongs to a group of medicines called beta-blockers . It works by making the heartbeat slower and with less force.

Atenolol Actavis is used to:

– treat high blood pressure ( hypertension )

– treat certain types of irregular heartbeat ( arrhythmias )

– counteract chest pain (angina)

– protect the heart in the early treatment after a heart attack.

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

What you need to know before using Atenolol Actavis

Do not use Atenolol Actavis

– if you are allergic to atenolol or any of the other ingredients of this medicine (listed in section 6).

– if you have or have had any of the following heart problems:

* if you have heart failure that is not under control (this often causes shortness of breath and swollen ankles).

* if you have grade II or III heart block (a condition that can be treated with a pacemaker).

* if you have had a collapse caused by severe heart problems (a condition called cardiogenic shock where the heart cannot pump enough blood in the body).

* if you have a special condition with an irregular heartbeat called sick sinus syndrome.

* if you have a very slow heart rate (less than 45-50 beats per minute) or a very irregular heartbeat.

* if you have very low blood pressure .

* if you have very poor blood circulation in the arms and legs (which can lead to tingling in the fingers and toes or that they turn white or have a bluish tone).

– if you have a tumor called pheochromocytoma that is not treated. It is often located near the kidneys and can lead to high blood pressure .

– if your doctor has told you that you have high levels of acid in your blood (metabolic acidosis ).

– if you are taking certain medicines containing the active substance floctafenine.

– if you are given intravenous injections of certain medicines containing the active substance verapamil or diltiazem (used to treat heart problems).

– if you have severe asthma or other serious lung diseases (for example, severe COPD ( chronic obstructive pulmonary disease )).

Do not take Atenolol Actavis if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Atenolol Actavis.

Warnings and cautions

Talk to your doctor or pharmacist before taking Atenolol Actavis

– if you have asthma, wheezing, or similar breathing problems. If you have previously had asthma or wheezing, do not take this medicine without first consulting a doctor.

– if you get allergic reactions from, for example, insect bites, foods, or other substances. Allergic reactions can occur more quickly and become more severe. Atenolol may reduce the effect of adrenaline (used to treat severe allergic reactions).

– if you have a type of chest pain (angina) called Prinzmetal’s angina.

– if you have poor blood circulation in your arms and legs.

– if you have a mild disturbance of the heart rhythm (first-degree heart block).

– if you have a heart problem such as narrowing of the artery were (ischemic heart disease).

– if your heart rate is usually low. Atenolol can lower the heart rate further. If your heart rate drops below 55 beats per minute, your doctor will probably lower the dose ofatenolol.

– if you have diabetes. Your medicine may hide signs of low blood sugar, such as rapid heartbeat and tremors.

– if you have or have had psoriasis before.

– if you have thyrotoxicosis (a condition caused by an overactive thyroid gland ). Your medicine may mask the symptoms of thyrotoxicosis.

– if you are being treated for a tumor near the kidneys called pheochromocytoma.

– if you have kidney problems. You may then need to go for check-ups during the treatment.

– if you are to be anesthetized. Tell your anesthetist that you are taking atenolol.

Talk to your doctor or pharmacist before taking Atenolol Actavis if you are not sure if any of the above applies to you.

Other medicines and Atenolol Actavis

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines. This is because Atenolol Actavis can affect and be affected by other medicines.

In particular, tell your doctor if you are taking any of the following medicines:

floktafenine (used to treat pain and swelling) (see “Do not use Atenolol Actavis” in this section)

– verapamil or diltiazem (used to treat heart problems) (see “Do not use Atenolol Actavis” in this section)

– clonidine (for high blood pressure or migraine ). If you take clonidine and Atenolol Actavis together, do not stop taking clonidine without your doctor’s approval. If you have to stop taking clonidine , your doctor will give you detailed instructions on how to do this.

– nifedipine (for high blood pressure or chest pain).

– disopyramide, quinidine, or amiodarone (for irregular heartbeats)

– digoxin (for heart problems)

– MAO inhibitors (used to treat depression)

sultoprid (used to treat mental health problems)

– adrenaline, also called epinephrine (a heart-stimulating drug)

– medicines that relieve pain and inflammation (eg ibuprofen, indomethacin, aspirin, or diclofenac )

– insulin or diabetes medications you take by mouth

– baclofen (a muscle relaxant)

– tricyclic antidepressants, barbiturates, or phenothiazines (for depression and insomnia)

– ampicillin ( antibiotic for bacterial infections)

– lidocaine and procainamide (for heart problems)

– X-ray contrast

Operations

If you are going to have surgery, tell your anesthetist or healthcare professional that you are taking Atenolol Actavis. This is because your blood pressure may drop if you are given certain anesthetics while taking Atenolol Actavis.

Atenolol Actavis with food and drink

Blood pressure may drop if you take alcohol while using Atenolol Actavis.

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.

Atenolol Actavis is not recommended during pregnancy or lactation.

Driving and using machines

Your medicine probably does not affect your ability to drive or use tools or machines. However, it is best to wait and see how you are affected by the medicine before doing any of these.

If you feel dizzy or tired while taking this medicine, do not drive or use any tools or machines.

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.

How to use Atenolol Actavis

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

Your doctor will tell you how many tablets to take each day and when to take them.

Read the label on the box as a reminder of your doctor’s instructions.

Swallow the Atenolol Actavis tablets whole with water.

Try to take the tablets at the same time each day.

Adults

High blood pressure ( hypertension )

The usual starting dose is 25 mg daily. The usual maintenance dose is 50 mg to 100 mg once a day.

Chest pain (angina)

The usual dose is 50 mg to 100 mg daily. A dose of 100 mg daily can be divided into two divided doses.

Irregular heartbeats ( arrhythmias )

The usual dose is 50 mg to 100 mg once a day.

Early treatment of myocardial infarction

The usual dose is 50 mg to 100 mg daily.

Older

If you are older, your doctor may decide to give you a lower dose, especially if you have kidney problems.

Patients with severe kidney problems

If you have severe kidney problems, your doctor may decide to give you a lower dose.

Use for children and adolescents

Atenolol Actavis is not recommended for children or adolescents under 18 years of age.

Symptoms of an overdose of Atenolol Actavis may include:

very slow heartbeat, very low blood pressure and shortness of breath.

If you forget to use Atenolol Actavis

If you forget to take a dose , take it as soon as you remember. However, if it is almost time to take your next dose , skip the missed dose . Do not take a double dose to make up for a forgotten dose .

If you stop using Atenolol Actavis

Do not stop taking Atenolol Actavis without consulting your doctor. In some cases, you may need to stop gradually.

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.

Allergic reactions:

If you get an allergic reaction , see a doctor immediately. Symptoms of this can be a rash or swelling of the face, lips, mouth, tongue or throat.

Other possible side effects:

Common (affects 1 to 10 users in 100)

  • slow pulse
  • cold hands and feet
  • upset stomachs, such as diarrhea, nausea, vomiting, or constipation
  • feeling tired.

Uncommon (affects 1 to 10 users in 1000)

  • restless sleep
  • liver problems (observed as elevated transaminase levels in blood tests).

Rare (affects 1 to 10 users in 10,000)

  • heart block (may cause dizziness, abnormal heartbeat, fatigue, or fainting)
  • numbness and tingling in the fingers followed by a hot feeling and pain (Raynaud’s syndrome)
  • mood swings
  • nightmares
  • Depression
  • confusion
  • personality changes ( psychoses ) or hallucinations
  • headache
  • dizziness (especially when standing up)
  • tingling, tingling or numbness in the skin
  • erection problem ( impotence )
  • dry mouth
  • dry eyes
  • visual disturbances
  • various skin reactions such as allergic skin rash, itching, hair loss, and inflammation
  • decreased number of platelets (this can lead to bruising more easily)
  • purple marks on the skin
  • jaundice (skin and whites of the eyes become yellowish).

Very rare (affects less than 1 user in 10,000)

  • changes in certain blood cells or other components of the blood. Your doctor may want to take blood samples at regular intervals to check if Atenolol Actavis is affecting your blood in any way.

No known frequency (cannot be calculated from the available data)

  • atenolol can mask the symptoms of a condition called thyrotoxicosis (thyroid problems)
  • atenolol may mask the symptoms of low blood sugar (in diabetes )
  • lupus-like syndrome (a disease in which the immune system produces antibodiesthat primarily attack the skin and joints).

Conditions that can worsen

The following conditions may worsen when you start taking the medicine. This occurs in rare cases and affects less than 1 in 1000 users.

– psoriasis (a skin disease)

– shortness of breath or swollen ankles (if you have heart failure )

– asthma or breathing problems

– pain and cramps in the legs that make you lame when you walk ( window disease )

– poor blood circulation.

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 Actavis

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 carton, bottle and blister after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

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. An Atenolol Actavis 25 mg film-coated tablet contains 25 mg of atenolol. An Atenolol Actavis 50 mg film-coated tablet contains 50 mg of atenolol. An Atenolol Actavis 100 mg film-coated tablet contains 100 mg of atenolol.

The other ingredients are Tablet core: microcrystalline cellulose (E460), maize starch, crospovidone type A (E1202), calcium hydrogen phosphate dihydrate (E341), colloidal anhydrous silica, magnesium stearate (E572), hydrogenated sodium laurel oil; Film coating: titanium dioxide (E171), hypromellose, propylene glycol (E1520), talc (E553b).

What the medicine looks like and contents of the pack

Atenolol Actavis 25 mg: a white, round, biconvex film-coated tablet with a scoreline and imprinted with AI on one side.

Atenolol Actavis 50 mg: a white, round, biconvex film-coated tablet with a scoreline and imprinted with AH on one side.

Atenolol Actavis 100 mg: a white, round, biconvex film-coated tablet with a scoreline and embossed with AJ on one side.

The tablet can be divided into two equal parts.

Pack sizes

Blister (PVC / Al)

Atenolol Actavis 25 mg film-coated tablets: 20, 30, 90 and 100 film-coated tablets

Atenolol Actavis 50 mg film-coated tablets: 20, 30, 50, 90 and 100 film-coated tablets

Atenolol Actavis 100 mg film-coated tablets: 20, 30, 42, 90 and 100 film-coated tablets

Tablet jar (HDPE) with a plastic screw cap (PP)

Atenolol Actavis 25 mg film-coated tablets: 20, 30, 100, 250 and 500 film-coated tablets

Atenolol Actavis 50 mg film-coated tablets: 20, 30, 100, 250 and 500 film-coated tablets

Tablet jar (HDPE) with plastic lid (HDPE)

Atenolol Actavis 100 mg film-coated tablets: 20, 30, 100, 250 and 500 film-coated tablets

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjordur

Iceland

Manufacturer

Actavis UK Limited

Whiddon Valley, Barnstaple

EX32 8NS North Devon

UK

Balkanpharma – Dupnitsa AD

3, Samokovsko Shose Str.

2600 Dupnitsa

Bulgaria

Muhammad Nadeem

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