Atenolol tablets BP 100 mg – patient leaflet, side effects, dosage

1. What Atenolol is and what it is used for

Atenolol belongs to a group of medicines called beta-blockers, which help to slow the heart beat and relax blood vessels. This reduces blood pressure and the heart's demand for oxygen.

Atenolol is used to treat:

• High blood pressure (hypertension)
• Chest pain (angina pectoris)

• Irregular heartbeat (cardiac

  dysrhythmias)

• Protect the heart after a heart attack

2. What you need to know before you take Atenolol

Do not take Atenolol if:

• You are allergic to Atenolol or any of the other ingredients of this medicine (listed in section 6)
• You have ever had asthma or wheezing
• You have uncontrolled heart failure
• You have chest pain when at rest (Prinzmetals angina)
• You suffer from a weakened heart unable to pump blood around the body (cardiogenic shock)
• You have second or third degree heart block
• You have a very slow heart rate (severe bradycardia)
• You suffer from an irregular heartbeat (sick sinus syndrome)

• You have low blood pressure

  (hypotension)

• You have phaeochromocytoma (tumour of the adrenal gland)
• You have very poor circulation (intermittent claudication)
• You suffer from an increased level of acid in the blood (metabolic acidosis)

Warnings and precautions

Talk to your doctor before taking Atenolol if:

• You are due to have surgery (see "Other medicines and Atenolol" section and section 3 "If you stop taking Atenolol")
• You have controlled heart failure or you suffer from heart disease or have been taking Atenolol for a long time as your treatment should be withdrawn slowly over 1-2 weeks
• You have a slow heart rate as you may require a lower dose
• You are diabetic as Atenolol may hide the symptoms of low blood sugar levels (hypoglycaemia)
• You suffer from an overactive thyroid (hyperthyroidism) as Atenolol may hide the symptoms
• You have kidney or liver problems as you may require a lower dose
• You suffer from psoriasis (skin disease causing scaly pink patches), as Atenolol may aggravate this condition
• You have first degree heart block
• You suffer from high blood pressure (portal hypertension)
• You have a history of serious allergic reaction (anaphylaxis) as your usual dose of adrenaline (epinephrine) used to treat allergic reactions may not work and may increase the likelihood of muscle weakness (myasthenia gravis)

Other medicines and Atenolol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without prescription. This includes herbal medicines.

Other medicines which may interact with or be affected by Atenolol:

• If you are due to have an anaesthetic you must tell the medical staff that you are taking Atenolol. Anaesthetics such as ether, cyclopropane, trichloroethane, halothane and enflurane should be avoided
• If you are going to have an X-ray that involves using a substance containing iodine (called a "contrast media"), you should tell the medical staff that you are taking Atenolol
• Aldesleukin, used to treat kidney cancer
• Alprostadil, used to treat erectile dysfunction
• Ampicillin, used to treat bacterial infections
• Antihypertensives (used to treat high blood pressure such as methyldopa, ACE Atenolol 50mg and

100mg Film-Coated Tablets

inhibitors, angiotensin-II antagonists, alpha blockers such as prazosin, calcium channel blockers such as diltiazem, nifedipine, nisoldipine and verapamil, vasodilators such as diazoxide and hydralazine and diuretics)

• Mefloquine, used to reduce the risk of infection with malaria
• Benzodiazepines, used to reduce anxiety and induce sleep
• Medicines for heart conditions such as digoxin (cardiac glycosides)
• Clonidine, used for high blood pressure or migraine. Atenolol should be discontinued several days before slowly stopping clonidine
• Ergot alkaloids, used to treat headaches and migraines
• Moxisylyte, used to treat Raynaud's phenomenon
• Muscle relaxants such as atricurium
• Levodopa, used to treat Parkinson's disease
• Parasympathomimetics such as neostigmine (used to simulate nervous system)
• Theophylline, used to treat asthma
• Antiarrhythmics, such as disopyramide, quinidine and amiodarone (used to treat heart rhythm disorders)
• Anticholinesterase agents, used to treat heart conditions
• Medicines used to treat depression and mental health conditions such as phenothiazines, tropisetron and monoamine oxidase inhibitors (MAOIs)

• Adrenaline (epinephrine) and

  noradrenaline, used to treat severe allergic reactions (sympathomimetics)

• Insulin or oral medicines, used to treat diabetes. Atenolol increases the risk of developing low blood sugar levels (hypoglycaemia) and may mask the symptoms of low blood sugar levels (hypoglycaemia)
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin (used for pain relief and inflammation)
• Antacids, such as calcium or aluminium and magnesium (used to treat indigestion and heartburn)

Taking this medicine with alcohol

It is recommended that you do not drink alcohol whilst being treated with Atenolol as it could cause a lowering of your blood pressure.

Pregnancy and breast−feeding

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

Pregnancy

• Atenolol should not be taken in early pregnancy (first and second trimesters – 1-6 months), before or during childbirth.
• Atenolol may be given under close supervision for the treatment of pregnancy associated high blood pressure (hypertension) in the third trimester of pregnancy (last 3 months).

Breast-feeding

This medicine passes into breast milk. Breast-feeding may be undertaken but the infant should be monitored for signs of low blood sugar levels (hypoglycaemia), breathing more slowly or weakly than usual (respiratory depression), low blood pressure (hypotension) and slow heartbeat (bradycardia).

Driving and using machines

Your medicine is unlikely to affect your ability to drive. However some people may occasionally feel dizzy or tired (fatigue) when taking Atenolol. If affected you should not drive or operate machinery.

Atenolol contains Sunset Yellow (E110)

May cause allergic reactions.

3. How to take Atenolol

Always take Atenolol exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• These tablets are to be taken orally

Adults:

High blood pressure (hypertension)

• The usual dose is 100mg Atenolol daily as a single dose.
• Some patients may only need one 50mg tablet daily.
• It can take 1-2 weeks for Atenolol to work fully.
• Atenolol can be used with other antihypertensive medicines.

Chest pain (angina pectoris)

The usual dose is 100mg Atenolol once daily or 50mg twice daily.

Abnormal heart rhythm (cardiac dysrhythmias)

The maintenance dose is 50 to 100mg Atenolol daily as a single dose.

Heart attack (myocardial infarction)

• 15 minutes after the intravenous dose, one 50mg tablet is taken orally followed by a further 50mg tablet 12 hours after the intravenous dose.
• After an additional 12 hours, one 100mg tablet is taken orally, once daily.

Elderly

Your doctor may reduce your dose especially if you suffer from poor kidney function.

Patients with kidney problems

If you suffer from kidney problems, your dose will be adjusted.

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DATE: 30/01/2023 VERSION: 00 DATE: 08/02/2023 VERSION: 01 DATE: 09/02/2023 VERSION: 02 DATE: 15/02/2023 VERSION: 03 Use in children

Atenolol should not be taken by children. If you take more Atenolol than you should

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.

Symptoms of an overdose include:

dizziness, fainting (syncope), low blood sugar levels (hypoglycaemia), slow heartbeat (bradycardia), heart rhythm disorders, low blood pressure (hypotension), breathing problems (bronchospasm, respir-atory depression, bronchoconstriction), heart failure, fits (convulsions), coma. If you forget to take your Atenolol

Take it as soon you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

If you stop taking Atenolol

• It is important that you keep taking Atenolol for as long as your doctor has told you to
• Stopping treatment with this medicine should be done gradually over a period of 1-2 weeks
• You should be monitored by your doctor whilst stopping, especially if you suffer from heart problems or have been taking Atenolol for a long time
• Sudden discontinuation of treatment with Atenolol may aggravate chest pain (angina pectoris), high blood pressure (hypertension), heart attack (myocardial infarction), abnormal heart rhythm and sudden (heart) death
• If you are due to have surgery and your doctor decides to stop your treatment with Atenolol, this should be done at least 24-48 hours before the operation

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Seek medical advice immediately if you develop the following:

• Allergic reaction: swelling of the face, throat or tongue, difficulty breathing (anaphylaxis) or dizziness

• Swelling of the deeper layers of the skin caused by a build-up of fluid

  (angioedema)

• Wheezing, breathlessness, abdominal pain, diarrhoea, fever, cough and rashes due to an increase in a certain type of white blood cells (eosinophilia) • Rare and potentially life-threatening inflammation causing blockage of the bowel (sclerosing peritonitis)

Common side effects (may affect up to 1 in 10 people)

• Slower heartbeat (bradycardia) • Cold hands and feet
• Diarrhoea
• Feeling tired (fatigue)
• Feeling sick (nausea) or being sick (vomiting)
• Constipation
• Stomach cramps
• Condition where extra fibrous tissue forms in the area behind the stomach and intestines (retroperitoneal fibrosis)

Uncommon side effects (may affect up to 1 in 100 people)

• Increase in liver enzyme levels (detected through blood tests)

Rare side effects (may affect up to 1 in 1,000 people)

• Heart failure, heart block
• Poor blood circulation which makes the toes and fingers numb and pale (Raynaud's phenomenon)
• Decay of body tissue due to a lack of blood supply (necrosis, gangrene) • Depression
• Mood changes
• Abnormal dreams and nightmares, sleep disturbances
• Feeling confused
• Anxiety
• Changes in personality (psychoses) • Seeing or hearing things that are not real (hallucinations)
• Headache
• Low blood pressure which may include fainting (syncope) and dizziness when changing position (postural hypotension) • Worsening of pain and/or cramping in the lower leg (intermittent claudication) • Tingling or numbness in the hands or feet (paraesthesia)
• Being unable to get an erection (impotence)
• A condition in which scar tissue develops along the shaft of the penis (Peyronie's disease)
• Dry mouth
• Drowsiness
• Liver problems including a pregnancy- related liver disorder causing build-up of bile acids in the bloodstream causing persistent itch (intrahepatic cholestasis) • Sweating
• Severe itching (pruritus)
• Disturbances of vision including blurred vision, sore eyes, dry eyes (reversible on withdrawal), conjunctivitis (infection that causes inflammation of the eye, red eyes, itchiness and discharge)

• Hair loss (alopecia - reversible) • Skin rash or worsening of psoriasis (skin disease causing scaly pink patches) • Reduced numbers of platelets in your blood, which may increase the risk of bleeding or bruising (thrombocytopenia)

  • A reduction in white blood cells (leucopenia)
  • More prone to infections due to a severe reduction in number of white blood cells (agranulocytosis)
  • Skin rash caused by small blood vessels bleeding into the skin (purpura) • Worsening of shortness of breath or having swollen ankles (if you have heart failure).
  • Worsening of asthma or breathing problems
  • Inflammation of the lungs (pneumonitis) and/or lining surrounding the lungs (pleurisy)
  • Shortness of breath or difficulty in breathing (dyspnoea)
  • Condition that causes scarring of the lungs (pulmonary fibrosis)
  • Disorders of the nervous system e.g. "creeping" sensation and other sensory disorders affecting hands and/or feet (peripheral neuritis)
  • A lack of energy (lethargy)
  • Memory impairment and/or loss of memory (amnesia)
  • An increase in ANA (Antinuclear Antibodies)

Other side effects (frequency not known)

• A sensation of whirling and loss of balance, feeling dizzy or giddy (vertigo) • Condition which causes joint pain, skin rashes and fever (Lupus-like syndrome) • High (hyperglycaemia) or low blood sugar levels (hypoglycaemia)
• Muscle cramps
• Pain or swelling in the joints (arthralgia) • Skin rashes with the formation of wheals (urticaria)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme

at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Atenolol

• Keep this medicine out of the sight and reach of children.
• Do not use Atenolol after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Store in the original package in order to protect from heat, light and moisture. • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Atenolol contains:

Each film-coated tablet contains 50mg or 100mg of Atenolol.

The other ingredients are:

AC-DI-SOL SD 711, calcium hydrogen phosphate, microcrystalline cellulose, hydroxypropylmethylcellulose 6 CP, magnesium stearate, povidone, starch 1500, quinoline yellow aluminium lake (E104), sunset yellow aluminium lake (E110) and titanium dioxide

(E171), Polyethylene glycol/Macrogol, isopropyl alcohol and purified water.

What Atenolol looks like and contents of the pack:

• Orange, film-coated normal convex tablet, debossed with 50 on one face and plain on the other face.
• Orange, film-coated normal convex tablet, debossed with 100 on one face and plain on the other face.

Atenolol is available in:

Atenolol Tablets are available in blister packs containing 28 or 30 tablets. Not all pack sizes may be marketed.

Product Licence Numbers:

Atenolol 50mg Tablets: PL 51718/0002 Atenolol 100mg Tablets: PL 51718/0003

Marketing Authorisation Holder and Manufacturer:

Clydesdale Pharma Ltd.,

Unit 3-4 Campbell Court

Campbell Road,

Tadley

RG26 5EG

United Kingdom.

This leaflet was last revised in

February 2025

CP0002-03.LT.V2

Size: 120 x 480 mm

Colour Uses:

120 mm

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