Loniten

Package leaflet: information for the patient

LONITEN 5 mg tablets

Minoxidil
Please read this leaflet carefully before you or your child take 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, the doctor treating your child, or your pharmacist.
• This medicine has been prescribed for you or your child only. Do not give it to others, even if their symptoms are the same as yours, because it could be dangerous.
• If you notice any side effect, including those not listed in this leaflet, talk to your doctor, the doctor treating 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 taking/giving 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 Loniten is and what it is used for

Loniten contains the active substance minoxidil, which works by dilating blood vessels, thereby
reducing blood pressure.
Loniten is used in adults and children for:

• 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 urine
production, and a beta-blocker (or similar medicine) that reduces heart rate.

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

Do not take/give Loniten to your child

• if he/she is allergic to minoxidil or to any of the other ingredients of this medicine (listed in section 6);
• if he/she has a benign tumour called phaeochromocytoma.

Warnings and precautions
Talk to your doctor, your child’s doctor, or pharmacist before taking/giving Loniten to your child.
Tell the doctor, your child’s doctor, or pharmacist before taking/giving this medicine if:

• your child has severe heart problems. Loniten increases fluid retention in the body, which may worsen heart conditions;
• your child has kidney problems, and whether or not he/she is on dialysis, a blood filtration procedure;
• your child has had a heart attack.

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

• fluid retention within the body. Excessive fluid in the body may cause swelling and weight gain, and may prevent Loniten from working effectively. Your 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 acute chest pain ( angina pectoris );
• increased hair growth, especially on the face. This effect usually resolves within 1 to 6 months after stopping Loniten treatment;
• changes in heart parameters (changes in electrocardiogram or ECG). If you/your child need heart monitoring tests, inform the doctor that you are being treated with Loniten;
• reduced number of platelets and white blood cells in the blood;
• inflammation of the pericardium, the membrane surrounding the heart, or fluid accumulation around the heart. Your doctor will carry out careful monitoring to prevent or promptly treat these events.

Other medicines and Loniten
Tell the doctor, your child’s doctor, or pharmacist if you/your child are taking, have recently taken, or might take any other medicine.
It is particularly important to inform the doctor if you/your child are taking other medicines that lower blood pressure (e.g. guanethidine and bethanidine). These medicines may interact with Loniten, causing excessive lowering of blood pressure and/or a sudden drop in blood pressure upon standing.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
If you are pregnant, your doctor will prescribe this medicine only if strictly necessary. If you are a woman of childbearing age, you should use adequate contraceptive methods to avoid pregnancy during treatment with Loniten.
Loniten passes into breast milk. Your doctor will decide whether it is better for you to stop breastfeeding or to discontinue treatment with this medicine, taking into account the benefits and risks for you and your child.

Driving and using machines
It is not known whether this medicine affects the ability to drive or use machinery.
If any side effect occurs that may affect these abilities, avoid driving or using machinery.

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

3. How to take/give Loniten to the child

Take/give this medicine to the child exactly as directed by the doctor. If you have any doubts, consult the 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 those with severe hypertension associated with organ damage, after failure of previous treatments, and must be initiated only under the supervision of a specialist in a hospital setting. The doctor will perform regular check-ups on your child to determine the most appropriate dose of Loniten and other medications, and to monitor their condition.
The recommended starting dose is 0.2 mg per kg of body weight, taken either as a single dose or divided into multiple administrations. The doctor will gradually increase the dose of Loniten until reaching the most suitable dose for your child.
The maximum recommended dose is 50 mg per day.

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

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

If you take/give more Loniten than you/your child should
If you think you have taken or given your child more Loniten than you should, contact the doctor, the doctor treating your child, or the pharmacist immediately, as a severe drop in blood pressure may occur.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately inform your doctor if you or your child experience the following side effects as they are serious:

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

Contact your doctor if you or 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 growth of body hair (see section 2 “Warnings and precautions”)
• change in hair colour
• 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 various parts of the body (see section 2 “Warnings and precautions”)
• stomach and intestinal disorders

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

• breast tenderness

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

• decrease in the number of platelets and white blood cells in the blood
• skin inflammation and blistering
• skin rash

Not known (frequency cannot be estimated from the 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 effect, including those not listed in this leaflet, talk to your doctor, the doctor treating your child, or your 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 Loniten

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "Exp". The expiry date refers to the last day of that month.
Store below 25°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine 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 Loniten contains

• The active substance is minoxidil. Each tablet contains 5 mg of minoxidil.
• The other components 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 Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Italy
Manufacturer
PFIZER MANUFACTURING BELGIUM N.V.
Rijksweg 12
B-2870 Puurs
Belgium
Pfizer Service Company BVBA
Hoge Wei 10
B - 1930 Zaventem
Belgium