Loniten 10 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Loniten 10 mg tablets
Minoxidil
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Loniten is and what it is used for
- What you need to know before taking Loniten
- How to take Loniten
- Possible side effects
- How to store Loniten
- Contents of the pack and other information
1. What Loniten is and what it is used for
Loniten belongs to a group of medicines called vasodilators. It is used to treat very high blood pressure (severe hypertension).
2. What you need to know before taking Loniten
Do not take Loniten:
- if you are allergic to minoxidil or to any of the other ingredients of this medicine (listed in section 6).
- if your high blood pressure is caused by hormones from a tumour (pheochromocytoma).
Warnings and precautions
Talk to your doctor before starting Loniten if:
- you have any kidney problems, as your doctor may consider it necessary to reduce the dose of minoxidil and monitor the levels of water and salts in your body.
- you have liver problems; your doctor may start treatment with a reduced once-daily dose and gradually increase it to the lowest effective dose needed to achieve the desired therapeutic effect.
- you have had a myocardial infarction (heart attack).
Be cautious with this medicine if during treatment you notice swelling in your limbs or other signs of fluid retention. Minoxidil may cause your body to retain water and salts. To prevent this, your doctor will always instruct you to take Loniten together with another antihypertensive medicine that promotes fluid elimination (a diuretic). It is important that you follow your doctor's instructions regarding taking this medicine and their dietary recommendations for a salt-free diet. Your doctor may also advise you to monitor your weight (an increase of 1 to 1.5 kg) to detect possible fluid retention, as this may reduce the effectiveness of Loniten.
Consult your doctor if during treatment you notice your heart beating faster (tachycardia) or experience chest pain or tightness (angina pectoris). Minoxidil is generally administered together with another medicine to lower blood pressure that helps prevent these symptoms.
During treatment, you may develop inflammation of the outer membrane surrounding the heart (pericarditis) and/or accumulation of fluid within this membrane (pericardial effusion), which may compress the heart (cardiac tamponade).
In most patients treated with minoxidil, excessive growth of body hair (hypertrichosis) occurs. When treatment is stopped, the previous appearance usually returns within 1 to 6 months.
If you are undergoing any diagnostic tests (including blood tests and electrocardiograms), inform your doctor that you are taking this medicine, as it may alter test results.
Children
During treatment with minoxidil, the child must be under the supervision of specialists. The daily dose of minoxidil will be determined by the specialist and may be adjusted according to the child's needs. During treatment, the child will additionally be treated with other medicines as decided by the specialist to prevent rapid heartbeat and fluid accumulation in the body. Consult your doctor if the child develops any of the following symptoms: very rapid heartbeat, rapid breathing, leg swelling, rapid weight gain, or reduced urine output. The child must have regular medical check-ups during treatment with minoxidil.
Use of Loniten with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
In particular, inform your doctor if you are taking other medicines to lower blood pressure. Taking minoxidil together with certain antihypertensive drugs (such as guanethidine and betanidine) may cause an excessive drop in blood pressure.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
This medicine is not recommended for use in pregnant women.
Excessive growth of body hair (hypertrichosis) has been reported in newborns of mothers who took Loniten during pregnancy.
Breastfeeding
The active ingredient of this medicine passes into breast milk. Therefore, use of this medicine is not recommended while breastfeeding unless otherwise directed by your doctor.
Fertility
This medicine is not recommended for women of childbearing potential who are not using reliable contraceptive measures.
Driving and use of machines
No studies have been conducted on the effects of minoxidil on the ability to drive and operate machinery. Since individual responses to treatment may vary, avoid performing tasks requiring special attention until you know how you tolerate this medicine.
Loniten contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult with him or her before taking this medicine.
3. How to take Loniten
Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor again.
Your doctor will decide which minoxidil dose is most appropriate for you. Do not take more tablets than specified by your doctor.
Take your dose of minoxidil once or twice daily, as advised by your doctor.
The tablets of this medicine can be swallowed whole with a little water.
Loniten is generally administered together with other medicines used for the treatment of high blood pressure that your doctor has prescribed for you.
Use in children and adolescents
The tablet may be divided into equal doses.
Adults and patients over 12 years of age:
The usual initial minoxidil dose for adults and children over 12 years of age is 5 mg per day. Afterwards, your doctor may gradually increase the dose at intervals of at least 3 days between each dose adjustment until reaching the most appropriate dose. The maximum dose is 100 mg per day.
Patients aged 12 years or younger:
Treatment in children must always be carried out under strict monitoring. For patients aged 12 years or younger, the dose will depend on body weight. As a guideline, the initial dose is 0.2 mg per kilogram of body weight per day. Afterwards, your doctor may gradually increase the dose at intervals of at least 3 days between each dose adjustment until reaching the most appropriate dose. The maximum dose is 50 mg per day.
If you take more Loniten than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at: 91 562 04 20 (indicating the medicine and the amount ingested).
An overdose of minoxidil may cause an excessive drop in blood pressure.
If you forget to take Loniten
Do not take a double dose to make up for missed doses.
If you forget to take a dose, take it as soon as you can. However, if it is almost time for your next dose, do not take the missed tablet.
If you stop taking Loniten
Do not stop taking the tablets of this medicine unless instructed by your doctor, as this medicine helps you keep your blood pressure under control.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The possible adverse effects include:
Very common adverse effects (affect more than 1 in 10 people):
- faster heartbeats (tachycardia), inflammation of the outer membrane covering the heart (pericarditis)
- excessive growth of body hair (hypertrichosis), changes in hair color
- changes in the electrocardiogram
Common adverse effects (affect up to 1 in 10 people):
- fluid retention, swelling caused by fluid accumulation (edema)
- accumulation of fluid within the membranes surrounding the heart (pericardial effusion), which may compress the heart (cardiac tamponade)
- gastrointestinal discomfort
Uncommon adverse effects (affect up to 1 in 100 people):
- accumulation of fluid within the membranes surrounding the lung (pleural effusion)
- breast tenderness
Rare adverse effects (affect up to 1 in 1,000 people):
- low number of white blood cells (leucopenia), low number of platelets (thrombocytopenia)
- skin rash, blistering rash (bullous dermatitis), widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
Adverse effects of unknown frequency:
- swelling of the limbs (peripheral edema), which may sometimes be accompanied by weight gain
- chest pain or tightness (angina pectoris)
- temporary increase in certain blood substances (creatinine and urea) detectable in blood tests
- serious skin disease characterized by blisters and skin peeling (toxic epidermal necrolysis)
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Loniten
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging following EXP. The expiry date is the last day of the month indicated.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Loniten
The active substance is minoxidil. Each tablet contains 10 mg of minoxidil.
The other components (excipients) are: microcrystalline cellulose, corn starch, monohydrate lactose, colloidal silicon dioxide, and magnesium stearate.
Nature of the product and pack size
White, round, biconvex tablets, printed with "10" on the un-scored side and on the opposite scored side, printed with "U" on one side of the score and "137" on the other side.
The tablet can be divided into equal doses.
Loniten 10 mg tablets are available in PVC/aluminum blisters. Each pack contains 30 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Pfizer, S.L.
Av. de Europa, 20-B
Parque Empresarial La Moraleja
28108 Alcobendas (Madrid)
Spain
Manufacturer
Pfizer Service Company BV
Hermeslaan 11
1932 Zaventem
Belgium
This leaflet was approved in October 2015
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es