LONITEN 5 мг Коированная таблетка

Содержание инструкции

1. LONITEN 5 mg tablets
   1. What is Loniten and what is it used for
   2. What you need to know before taking/giving Loniten to the child
2. Loniten to act effectively. The doctor will advise you to follow a low-salt diet and will prescribe Loniten together with a diuretic to help the body
   1. How to take/give Loniten to the child
   2. Possible side effects
   3. How to store Loniten
   4. Contents of the pack and other information

LONITEN 5 mg tablets

Minoxidil

Read this leaflet carefully before you take/give this medicine to your child as 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 the doctor caring for your child, or your pharmacist.
• This medicine has been prescribed only for you or your child. Do not give it to other people, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or the doctor caring for your child, or your pharmacist. See section 4.

Contents of this leaflet:

• 1. What Loniten is and what it is used for
• 2. What you need to know before you take/give Loniten to your child
• 3. How to take/give Loniten to your child
• 4. Possible side effects
• 5. How to store Loniten
• 6. Contents of the pack and other information

1. What is Loniten and what is it used for

Loniten contains the active substance minoxidil, which works by dilating blood vessels and this
causes a reduction in blood pressure.
Loniten is used in adultsand childrenfor:

• the treatment of high blood pressure, when other medicines have proven ineffective (refractory hypertension).

Loniten must be taken together with two other medicines: a diuretic, which increases the
production of urine, and a beta-blocker (or similar medicine) that reduces the heart rate.

2. What you need to know before taking/giving Loniten to the child

Do not take/give Loniten to the child

• if they are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6);
• if they have a benign tumor called pheochromocytoma.

Warnings and precautions
Consult your doctor, the doctor caring for your child, or your pharmacist before
taking/giving Loniten to the child.
Inform your doctor, the doctor caring for your child, or your pharmacist before
taking/giving this medicine to the child if:

• they suffer from serious heart problems. Loniten increases fluid retention in the body and this can worsen heart conditions;
• they have kidney problemsand whether or not they are on dialysis, a blood filtration procedure;
• they have had a heart attack.

Duringtreatment with Loniten, you/your child may experience (see also
section 4 “Possible side effects”):

• fluid retentionwithin the body. Excessive amounts of fluid in the body can cause swelling and weight gain and may prevent

Loniten to act effectively. The doctor will advise you to follow a low-salt diet and will prescribe Loniten together with a diuretic to help the body

eliminate excess water;

• increased heart rate ( tachycardia) or severe chest pain ( angina pectoris);
• increased hair growth, especially on the face. This effect generally regresses after 1-6 months from the end of treatment with Loniten;
• alteration of cardiac parameters(changes in the electrocardiogram or ECG). If you/your child are to undergo tests to check the heart, inform the doctor that you are being treated with Loniten;
• reduction in the number of plateletsand white blood cellsin the blood;
• inflammation of the pericardium, the membrane surrounding the heart, or accumulation offluid around the heart. The doctor will subject you or your child to careful monitoring to prevent or promptly treat these episodes.

Other medicines and Loniten
Tell your doctor, the doctor caring for your child, or your pharmacist if you/your
child are taking, have recently taken, or might take any other
medicine.
It is particularly important that you inform your doctor if you/your child are taking
other medicines that lower blood pressure (e.g. guanethidineand betanidine). These
medicines may interact with Loniten causing an excessive decrease in
blood pressure and/or causing a sudden drop in blood pressure
when standing up.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.
If you are pregnant, the doctor will prescribe this medicine to you only if strictly
necessary. If you are a woman of childbearing potential, you should use adequate contraceptive methods to
avoid pregnancy during treatment with Loniten.
Loniten passes into breast milk. The doctor will assess whether it is preferable for you to stop
breastfeeding or the therapy with this medicine, considering the benefits and risks for
you and your child.

Driving and using machines
It is not known whether this medicine alters the ability to drive vehicles or operate machinery.
If you experience a side effect that may alter these abilities, avoid driving or
operating machinery.

Loniten contains lactose
Loniten contains lactose. If your doctor has diagnosed you with intolerance to some sugars,
contact him/her before taking this medicine.

3. How to take/give Loniten to the child

Take/give this medicine to the child following the instructions of the doctor exactly at all times. If you have any doubts, consult your doctor or pharmacist.
Swallow the tablets whole with a glass of water.

Use in children under 12 years of age
The use of Loniten in children should be limited to children with severe hypertension associated
with organ damage, after the failure of previous treatments and should only be started under
the supervision of a specialist in hospital. The doctor will subject your child to regular checks
to establish the most suitable dose of Loniten and other medicines for him and to assess his
condition.
The recommended initial dose is 0.2 mg per kg of body weight, to be taken all at once
or divided into multiple administrations. The doctor will gradually increase the dose of
Loniten until reaching the most suitable dose for your child.
The recommended maximum dose is 50 mg per day.

Use in children over 12 years of age and in adults
The recommended initial dose is 5 mg per day. Doses should be increased
gradually, at intervals of 3 or more days, up to a maximum dose of 100 mg per day,
to be taken all at once or divided into multiple administrations.

Use in people with kidney problems, undergoing dialysis or with liver problems
If you or your child have a kidney problem, are undergoing dialysis or have a liver problem,
lower doses of Loniten than those recommended may be necessary.

If you take/give more Loniten than you should
If you believe you have taken or given your child more Loniten than necessary, inform
your doctor or the doctor caring for your child or your pharmacist immediately, as
a serious decrease in blood pressure may occur.

If you forget to take/give Loniten to your child
Do not take/give your child a double dose to compensate for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor, the doctor caring for your child or your pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Inform your doctor immediatelyif you/your child experience the following side
effects because they are serious:

• inflammation of the pericardium (see section 2 “Warnings and precautions”)
• accumulation of fluid around the heart (pericardial tamponade, pericardial effusion) (see section 2 “Warnings and precautions”)
• severe chest pain (angina pectoris) (see section 2 “Warnings and precautions”)
• serious acute hypersensitivity reactions involving the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• excessive accumulation of fluid between the lung and the chest (pleural effusion)

See a doctor if you/your child experience the following side effects:

Very common(may affect more than 1 in 10 people):

• increased heart rate (tachycardia) (see section 2 “Warnings and precautions”)
• increased hair growth (see section 2 “Warnings and precautions”)
• change in hair color
• changes in heart parameters (changes in electrocardiogram) (see section 2 “Warnings and precautions”)

Common(may affect up to 1 in 10 people):

• fluid retention in the body and swelling in different parts of the body (see section 2 “Warnings and precautions”)
• stomach and intestinal disorders

Uncommon(may affect up to 1 in 100 people):

• breast sensitivity

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

• decreased number of platelets and white blood cells in the blood
• inflammation and formation of blisters on the skin
• skin rash

Not known(frequency cannot be estimated from available data):

• swelling of the feet and legs with or without weight gain
• increased levels of creatinine (a substance produced by muscles) and urea (a substance produced by the liver) in the blood.

Reporting of side effects
If you or your child experience any side effects, including those not
listed in this leaflet, please tell your doctor or the doctor caring for your child or your
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 Loniten

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and bottle
after “Exp”. The expiry date refers to the last day of that month.
Store at a temperature below 25° C. Store in the original package to
protect the medicine from humidity
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 Loniten contains

• The active ingredient is minoxidil. Each tablet contains 5 mg of minoxidil.
• The other ingredients are: microcrystalline cellulose, starch, colloidal silicon dioxide, magnesium stearate, lactose(see section 2 “Loniten contains lactose”).

Description of the appearance of Loniten and contents of the pack
Loniten is available in plastic bottles containing 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Italia S.r.l.
via Isonzo, 71
04100 Latina

Manufacturer
PFIZER MANUFACTURING BELGIUM N.V.
Rijksweg 12
B-2870- Puurs
Belgium
Pfizer Service Company BVBA
Hoge Wei 10

• B - 1930 Zaventem Belgium