BLOCADREN 10 mg Таблетки

Содержание инструкции

1. What BLOCADREN is and what it is used for
2. What you need to know before taking BLOCADREN
3. How to take BLOCADREN
4. Possible side effects
5. How to store BLOCADREN
6. Contents of the pack and other information

BLOCADREN 10 mg tablets
timolol maleate

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What BLOCADREN is and what it is used for
• 2. What you need to know before you take BLOCADREN
• 3. How to take BLOCADREN
• 4. Possible side effects
• 5. How to store BLOCADREN
• 6. 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 down the
heart rate and reduce the heart's workload. This reduces blood pressure and the demand
for oxygen from the heart.
BLOCADREN is used for:

• treating chest pain from angina pectoriscaused by an insufficient amount of oxygen reaching the heart (ischemic heart disease);
• treating high blood pressure (hypertension);
• preventing a new heart attack in people who have already had one (prophylaxis of coronary insufficiency);
• preventing headache attacks (migraine) in sufferers.

2. What you need to know before taking BLOCADREN

Do not take BLOCADREN

• if you are allergic to timolol maleate or any of the other ingredients of this medicine (listed in section 6);
• if you have uncontrolled heart failure, sick sinus syndrome (including sinoatrial block);
• if you have cardiac decompensation (the heart pumps less blood than it should);
• if you have sinus bradycardia, second and third degree AV block, cardiogenic shock (situations in which the heart beats too slowly);
• if you suffer from or have suffered from asthma or other respiratory problems (bronchospasm or chronic obstructive bronchopneumopathy);
• if you suffer from 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 which are used for depression;
• if you suffer from a condition that affects the adrenal glands called pheochromocytoma;
• if you have a condition that causes acidity of the blood called metabolic acidosis;
• if you have low blood pressure.

Warnings and precautions
Talk to your doctor before taking BLOCADREN and tell them:

• if you have diabetes and are being treated with insulin or other drugs for diabetes, or if your blood sugar levels sometimes drop too low (spontaneous hypoglycemia). This medicine can mask the symptoms due to a too low amount of sugar in the blood (hypoglycemia). It may be necessary to adjust the dose of insulin or antidiabetic drugs you are taking;
• if you have problems with your thyroid gland (thyrotoxicosis);
• if you suffer from myasthenia gravis(abnormal muscle weakness) as this medicine may worsen it;
• if you have problems with your liver or kidneys, as this medicine is eliminated from your body through these organs;
• if you have allergies, as this medicine may decrease your body's ability to respond to medicines against severe allergic reactions (anaphylaxis);
• if you have been told that the amount of blood reaching your brain is too low (cerebrovascular insufficiency);
• if you are going to have surgery under anesthesia (see section 2 “Other medicines and BLOCADREN”);
• of any heart problems, including slow heartbeat or coronary heart disease;
• if you suffer from lung diseases (e.g. COPD);
• if you suffer from corneal disease (eye);
• if you suffer from a skin condition called psoriasis;
• if you have poor circulation in your legs or arms.

It is important to discuss this with your doctor, because it may be necessary to stop treatment or
change the dose you are taking.

Children
This medicine is not recommended in children because safety and efficacy have not been proven.

Other medicines and BLOCADREN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
It is particularly important that you tell your doctor if you are taking or have recently taken any
of the following medicines:

• Reserpine, guanethidine, and other medicines known as “catecholamine-depleting drugs”, used for mental problems and to lower blood pressure. Combining these medicines can lower blood pressure too much.
• Quinidine (a medicine used for heart rhythm problems), as combining it with this medicine can increase the effect of BLOCADREN.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), used as painkillers, for fever and for inflammation. Combining these medicines can decrease the effect of BLOCADREN.
• Medicines known as calcium antagonists, used to treat high blood pressure (hypertension) or heart disease.
• Digitalis (e.g. digoxin), drugs 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, lignocaine, tocainide, diltiazem, amiodarone, nifedipine, or any of the medicines known as Class I antiarrhythmic agents).
• Other beta-blockers.
• Medicines known as tricyclic antidepressants used for the treatment of depression or medicines known as phenothiazines used for the treatment of other mental problems.
• Medicines known as barbiturates used for the treatment of sleep disorders.
• Medicines for the treatment of diabetes (e.g. insulin and oral antidiabetic drugs).
• 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-based preparations.
• Medicines known as prostaglandin synthesis inhibitors (e.g. ibuprofen, aspirin, indometacin).
• Medicines known as CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine).

If you are going to have surgery or go to the dentist, tell the hospital doctor or the
dentist that you are taking this medicine. The doctor may decide to gradually stop this medicine before anesthesia, as it may lower blood pressure or heart rate too much. You should not take a local anesthetic combined with adrenaline
while you are taking BLOCADREN.

BLOCADREN with food, drinks and alcohol
You should avoid excessive alcohol consumption while taking BLOCADREN.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Consult your doctor immediately if you think you are pregnant during treatment with
BLOCADREN.
If you are pregnant, take this medicine only if your doctor has considered it strictly necessary and under
their supervision.

Breastfeeding
Tell your doctor before starting treatment with BLOCADREN if you are breastfeeding or planning
to breastfeed.
The use of this medicine is not recommended if you are breastfeeding because there is a risk of serious
side effects in the newborn. If your doctor believes that you should continue treatment
during this period, stop breastfeeding.

Driving and using machines
This medicine can cause fatigue, dizziness or visual disturbances. Do not drive vehicles or use
machinery until these symptoms have disappeared.

For athletes:the use of the drug without therapeutic need constitutes doping and
can still result in positive doping tests.

3. How to take BLOCADREN

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The doctor will adjust the dose and duration of treatment according to your condition and your response to treatment.
Any increases in the dose will be made gradually, your doctor will tell you how to do it.
This medicine must be taken by mouth and can be taken independently of meals.
The usual doses in adultsare:

Angina pectoris: the initial dose is 5 mg two or three times a day. The doctor will gradually increase
the dose based on your response to treatment.
The recommended dosage ranges from 15 to 45 mg per day to be taken in divided doses. In most
patients, a response is obtained with doses between 35 and 45 mg per day.
High blood pressure (arterial hypertension): the initial dose is 10 mg once or twice a day. The
doctor may gradually increase the dose based on the response to treatment. Doses higher than 20
mg per day should be taken in divided doses.
The maximum dose is 60 mg per day to be taken in divided doses.
Prophylaxis of coronary insufficiency (prevention of a new heart attack): the dose is 10 mg twice
a day.
Prevention of migraine attacks: the recommended dose ranges from 10 mg to 20 mg administered in
a single dose.

If you have kidney problemsyour doctor may reduce your dose to avoid your blood
pressure dropping too low.

Use in children
This medicine is not recommended for children (see section 2).

If you take more BLOCADREN than you should
If you take a dose of this medicine higher than the prescribed one immediately inform your
doctoror go to the nearest hospital. Bring this leaflet with you.
Symptoms of overdose may include: headache, dizziness, slowed heartbeat (bradycardia), low blood
pressure (hypotension), breathing problems
(bronchospasm), decreased amount of blood pumped by the heart (acute heart failure),
deterioration of consciousness.

If you forget to take BLOCADREN
If you forget to take a dose, do not take the forgotten dose. Take the next dose at the
usual time.
Do not take a double dose to make up for the missed 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 it may
worsen angina pectorisand in some cases cause a heart attack.
The doctor will gradually reduce the dosage over one or two weeks.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
manifest them.

Tell your doctor immediatelyif you experience any of the following side effects that
may occur with the use of this medicine:

• difficulty breathing or worsening of asthma;
• slowed heartbeat (bradycardia), heart rhythm abnormalities (arrhythmias, second and third degree atrioventricular block, sinoatrial block), temporary loss of consciousness (syncope), fluid retention (edema and pulmonary edema), decreased amount of blood pumped by the heart (heart failure or cardiac insufficiency or worsening of heart failure), low blood pressure (hypotension), limping (claudicatio), cardiac arrest, stroke, poor blood circulation (Raynaud's phenomenon), worsening of angina pectoris(chest pain), dilation of blood vessels (vasodilation), palpitations (feeling of a fast or strong heartbeat);
• bluish-purple discoloration of skin and mucous membranes (cyanosis)
• signs of stroke such as difficulty speaking, weakness in the limbs and facial alteration (facial drooping);
• allergic reaction: symptoms 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 based on available data):

• joint pain or stiffness;
• symptoms of retroperitoneal fibrosis including: abdominal and back pain, decreased urination or complete inability to urinate and decreased circulation to the legs leading to pain, swelling and discoloration;
• changes in laboratory tests;
• Systemic Lupus Erythematosus (Lupus) - symptoms include joint pain or stiffness, extreme fatigue;
• urticaria, skin irritation, localized or generalized skin rash, itching, anaphylactic reaction, alteration of skin color (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 the hands or feet, or leg pain induced by exercise, altered sensation (paresthesia);
• nausea (feeling unwell), vomiting, diarrhea, stomach pain (dyspepsia) or cough;
• increased liver size (hepatomegaly);
• altered sensitivity of the limbs or other parts of the body (paresthesia), dizziness or feeling lightheaded, headache, vertigo or feeling faint, nervousness, cerebral ischemia, drowsiness, decreased ability to concentrate;
• increased blood sugar (hyperglycemia), decreased blood sugar (hypoglycemia);
• difficulty breathing (dyspnea, bronchospasm), wheezing, cough;
• visual disturbances, blurred vision or double vision (diplopia), eye irritation/dryness, inflammation or redness of the eyes (blepharitis, keratitis), eye disorders (decreased corneal sensitivity, corneal erosion) involuntary lowering of the eyelids (ptosis), pain and decreased vision after eye surgery;
• depression, hallucinations, disorientation, confusion, memory loss or other mental problems, insomnia, sleep disturbances or nightmares, increased dreaming;
• dry mouth or altered taste (dysgeusia);
• sexual dysfunction (impotence), decreased sexual desire (libido);
• hair loss (alopecia);
• worsening of psoriasis;
• feeling tired/fatigued, decreased ability to perform physical exertion, pain in hands and feet, weight loss and fever.
• small skin hemorrhages that appear as reddish-purple spots (non-thrombocytopenic purpura);
• blood tests may show an increase in antibody levels;
• significant changes in some parameters measured with blood tests, such as: nitrogen levels (azotemia), potassium levels (potassemia), uric acid levels (uricemia), hemoglobin and hematocrit levels.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at: 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 pack 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 any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BLOCADREN contains

• The active ingredient is timolol maleate. Each tablet contains 10 mg of timolol maleate.
• The other ingredients are microcrystalline cellulose, corn starch, indigotine (E 132), magnesium stearate.

Description of the appearance of BLOCADREN and contents of the pack
BLOCADREN 10 mg tablets are presented in a pack of 40 tablets in Aluminum-Aluminum blisters.

Marketing authorisation holder and manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)