Patient Information Leaflet

BLOCADREN 10 mg tablets

timolol maleate
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What BLOCADREN is and what it is used for
What you need to know before taking BLOCADREN
How to take BLOCADREN
Possible side effects
How to store BLOCADREN
Contents of the pack and other information

1. What BLOCADREN is and what it is used for

BLOCADREN contains the active substance timolol maleate.
Timolol maleate belongs to a group of medicines known as beta-blockers, which slow the heart rate and reduce the workload of the heart. This reduces blood pressure and the heart's demand for oxygen.
BLOCADREN is used for:

treating chest pain due to angina pectoris caused by an insufficient supply of oxygen to the heart (ischaemic heart disease);
treating high blood (arterial) pressure (hypertension);
preventing a new heart attack in people who have already had one (prophylaxis of coronary insufficiency);
preventing migraine headaches in individuals who suffer from them.

2. What you should know before taking BLOCADREN

Do not take BLOCADREN

if you are allergic to timolol maleate or to any of the other ingredients of this medicine (listed in section 6);
if you have uncontrolled heart failure, sick sinus syndrome (including sino-atrial block);
if you have heart failure (when the heart pumps less blood than it should);
if you have sinus bradycardia, second- or third-degree AV block, cardiogenic shock (conditions in which the heart beats too slowly);
if you have or have had asthma or other breathing problems (bronchospasm or chronic obstructive pulmonary disease);
if you have a type of chest pain called Prinzmetal's angina;
if you have problems with blood circulation;
if you are taking medicines known as monoamine oxidase inhibitors (MAOIs), used for depression;
if you have a condition affecting the adrenal glands called pheochromocytoma;
if you have a condition causing blood acidity called metabolic acidosis;
if you have low blood pressure.

Warnings and precautions
Talk to your doctor before taking BLOCADREN and inform him/her:

if you have diabetes and are being treated with insulin or other antidiabetic medicines, or if your blood sugar levels sometimes drop too low (spontaneous hypoglycemia). This medicine may mask the symptoms of low blood sugar (hypoglycemia). It may be necessary to adjust the dose of insulin or antidiabetic medicines you are taking. Timolol maleate may also increase the risk of severe hypoglycemia when used together with certain types of antidiabetic medicines called sulfonylureas (e.g. glipizide, gliclazide, glyburide, glimepiride, tolbutamide, or glipizide);
if you have thyroid problems (thyrotoxicosis);
if you have myasthenia gravis (abnormal muscle weakness), as this medicine could worsen it;
if you have liver or kidney problems, as this medicine is eliminated from your body through these organs;
if you have allergies, as this medicine may reduce your body’s ability to respond to treatments for severe allergic reactions (anaphylaxis);
if you have been told that the blood supply to your brain is too low (cerebrovascular insufficiency);
if you are scheduled for surgery under anesthesia (see section 2 “Other medicines and BLOCADREN”);
if you have any heart problems, including slow heartbeat or coronary artery disease;
if you have lung diseases (e.g. COPD);
if you have a corneal disease (eye);
if you have a skin condition called psoriasis;
if you have poor circulation in your arms or legs.

It is important to discuss this with your doctor, as it may be necessary to stop treatment or adjust the dose you are taking.
Children
This medicine is not recommended for children, as safety and efficacy have not been established.
Other medicines and BLOCADREN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important that you inform your doctor if you are taking or have recently taken any of the following medicines:

Reserpine, guanethidine, and other medicines known as “catecholamine-depleting agents”, used for mental disorders and to lower blood pressure. Combination with these medicines may excessively lower blood pressure.
Quinidine (a medicine used for heart rhythm problems), as combination with this medicine may increase the effect of BLOCADREN.
Non-steroidal anti-inflammatory drugs (NSAIDs), used as painkillers, to reduce fever, and to treat inflammation. Combination with these medicines may reduce the effect of BLOCADREN.
Medicines known as calcium antagonists, used to treat high blood pressure (hypertension) or heart diseases.
Digitalis agents (e.g. digoxin), medicines used to increase the force of heart contraction when it is insufficient (heart failure).
Any medicine for high blood pressure (e.g. clonidine or hydralazine).
Other medicines for heart problems (e.g. verapamil, disopyramide, lidocaine, tocainide, diltiazem, amiodarone, nifedipine, or any of the medicines known as class I antiarrhythmic agents).
Other beta-blockers.
Medicines known as tricyclic antidepressants used to treat depression, or medicines known as phenothiazines used to treat other mental disorders.
Medicines known as barbiturates, used to treat sleep disorders.
Medicines for diabetes (e.g. insulin and oral antidiabetic medicines).
An anti-ulcer medicine called cimetidine.
An antibiotic called rifampicin.
Medicines to improve circulation.
Medicines for breathing difficulties (e.g. salbutamol or isoprenaline).
Medicines for migraine known as ergot preparations.
Medicines known as prostaglandin synthetase inhibitors (e.g. ibuprofen, aspirin, indomethacin).
Medicines known as CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine).

If you are undergoing surgery or visiting your dentist, tell your hospital doctor or dentist
that you are taking this medicine. Your doctor may decide to gradually discontinue this
medicine before anesthesia, as it could excessively lower blood pressure or heart rate. You must not take a local anesthetic combined with adrenaline while taking BLOCADREN.
BLOCADREN with food, drinks and alcohol
You should avoid excessive alcohol consumption while taking BLOCADREN.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Contact your doctor immediately if you think you are pregnant while being treated with BLOCADREN.
If you are pregnant, take this medicine only if your doctor considers it strictly necessary and under medical supervision.
Breastfeeding
Inform your doctor before starting treatment with BLOCADREN if you are breastfeeding or planning to breastfeed.
The use of this medicine is not recommended during breastfeeding due to the risk of serious adverse effects in the newborn. If your doctor considers that you need to continue treatment during this period, breastfeeding must be discontinued.
Driving and using machines
This medicine may cause fatigue, dizziness, or visual disturbances. Do not drive or operate machinery until these symptoms have resolved.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

3. How to take BLOCADREN

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will adjust the dose and duration of treatment according to your condition and your response to therapy.
Any dose increases will be made gradually; your doctor will advise you accordingly.
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This medicine is taken orally and can be taken independently of meals.
The usual doses in adults are:
Angina pectoris: The initial dose is 5 mg two or three times daily. Your doctor will gradually increase
the dose according to your response to treatment.
The recommended dosage ranges from 15 to 45 mg daily, administered in divided doses. In most
patients, an adequate response is achieved with doses between 35 and 45 mg daily.
High blood pressure (arterial hypertension): The initial dose is 10 mg once or twice daily.
Your doctor may gradually increase the dose depending on your response to treatment. Doses exceeding 20
mg daily should be taken in divided doses.
The maximum dose is 60 mg daily, taken in divided doses.
Prophylaxis of coronary insufficiency (prevention of a subsequent heart attack): The dose is 10 mg twice
daily.
Prevention of migraine attacks: The recommended dose ranges from 10 mg to 20 mg given as a
single dose.
If you have kidney problems, your doctor may reduce your dose to avoid excessive lowering of blood
pressure.
Use in children
This medicine is not recommended for use in children (see section 2).
If you take more BLOCADREN than you should
If you take more of this medicine than prescribed, contact your doctor immediately or go to the nearest hospital.
Bring this leaflet with you.
Symptoms of overdose may include: headache (cephalaea), dizziness, slowing of the heartbeat (bradycardia),
low blood pressure (hypotension), breathing difficulties (bronchospasm), reduced amount of blood pumped by the heart (acute heart failure), and deterioration in consciousness.
If you forget to take BLOCADREN
If you forget to take a dose, do not take the missed dose. Take the next dose at the usual time.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking BLOCADREN
Do not stop taking this medicine without consulting your doctor.
Treatment with this medicine MUST NOT BE STOPPED ABRUPTLY, as this may worsen
angina pectoris and, in some cases, cause a heart attack.
Your doctor will gradually reduce your dose over a period of one or two weeks.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Immediately tell your doctor if you experience any of the following side effects which may occur with the use of this medicine:

breathing difficulties or worsening of asthma;

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slow heartbeat (bradycardia), irregular heartbeat (arrhythmias, second- and third-degree atrioventricular block, sino-atrial block), temporary loss of consciousness (syncope), fluid accumulation (edema and pulmonary edema), reduced amount of blood pumped by the heart (heart failure or worsening of heart failure), low blood pressure (hypotension), limping (claudication), cardiac arrest, stroke, poor blood circulation (Raynaud's phenomenon), worsening of angina pectoris (chest pain), dilation of blood vessels (vasodilation), palpitations (sensation of rapid or stronger heartbeat);
bluish-purple discoloration of the skin and mucous membranes (cyanosis);
signs of stroke such as difficulty speaking, limb weakness, and facial drooping;
allergic reaction: signs may include hives or skin rash, or swelling of the face, lips, mouth, tongue, or throat.

Other side effects
Not known (frequency cannot be estimated from the available data):

joint pain or stiffness;
symptoms of retroperitoneal fibrosis including: abdominal and lower back pain, reduced urination or complete inability to urinate, and reduced circulation in the legs leading to pain, swelling, and discoloration;
changes in laboratory tests;
systemic lupus erythematosus (lupus) – symptoms include joint pain or stiffness, extreme tiredness;
urticaria, skin irritation, localized or generalized rash, itching, anaphylactic reaction, skin color changes (increased pigmentation), sweating, exfoliative dermatitis, allergic dermatitis, psoriasiform dermatitis;
muscle pain or weakness, worsening of myasthenia gravis;
cold or bluish hands and feet, low blood pressure, "pins and needles", tingling in hands or feet, or leg pain induced by exercise, altered sensation (paresthesia);
nausea (feeling unwell), vomiting, diarrhea, stomach ache (dyspepsia), or cough;
enlargement of the liver (hepatomegaly);
altered sensation in limbs or other body parts (paresthesia), dizziness or feeling of emptiness in the head, headache, vertigo or feeling faint, nervousness, cerebral ischemia, drowsiness, reduced ability to concentrate;
increased blood sugar levels (hyperglycemia), decreased blood sugar levels (hypoglycemia);
difficulty breathing (dyspnea, bronchospasm), shortness of breath (rattles), cough;
visual disturbances, blurred vision or double vision (diplopia), eye irritation/dryness, inflammation or redness of the eyes (blepharitis, keratitis), eye disorders (reduced corneal sensitivity, corneal erosion), involuntary drooping of the eyelids (ptosis), pain and decreased vision after eye surgery;
depression, hallucinations, disorientation, confusion, memory loss or other mental problems, insomnia, sleep disorders or nightmares, increased dreaming;
dry mouth or altered taste (dysgeusia);
sexual dysfunction (impotence), decreased sexual desire (libido);
hair loss (alopecia);
worsening of psoriasis;
feeling of tiredness/fatigue, reduced ability to perform physical effort, pain in hands and feet, weight loss and fever.
small skin hemorrhages appearing as red-violet spots (non-thrombocytopenic purpura);
blood tests may show increased levels of antibodies;
significant changes in certain parameters measured by blood tests, such as: nitrogen levels (azotemia), potassium levels (hyperkalemia), uric acid levels (uricemia), hemoglobin and hematocrit levels.

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Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BLOCADREN

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 packaging after "Expiry".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BLOCADREN contains

The active substance is timolol maleate. Each tablet contains 10 mg of timolol maleate.
The other components are microcrystalline cellulose, maize starch, indigotine (E 132), magnesium stearate.

Description of the appearance of BLOCADREN and pack contents
BLOCADREN 10 mg tablets are supplied in a pack containing 40 tablets in Aluminium-Aluminium blisters.
Marketing Authorisation Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
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