Patient Information

Loniten 10mg Tablets

Minoxidil

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Loniten and what it is used for

2.What you need to know before you start taking Loniten

3.How to take Loniten

4.Possible side effects

5.Storage of Loniten

6.Contents of the pack and additional information

Lonitenbelongs to a group of medicationscalledvasodilators. It is used for thetreatment ofsevere high blood pressure (malignant hypertension).

Do not take Loniten:

• if you are allergic to minoxidil orany of the other components of this medication (listed in section 6).
• if your high blood pressure is caused by hormones from a tumor (pheochromocytoma)

Warnings and precautions

Consult your doctor before starting to take Loniten if:

• you have any kidney problems, as your doctor may need 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 your treatment with a reduced dose once a day and gradually increase it to achieve the desired therapeutic effect at the lowest effective dose.
• you have had a heart attack

Be careful with this medication if during treatment you notice that your limbs are swollen or you notice other signs of fluid retention. Minoxidil can cause your body to retain water and salts. To avoid this, your doctor will always advise you to take Loniten with another blood pressure medication that helps eliminate fluids (diuretics). It is essential to follow your doctor's instructions on taking this medication and their recommendations on a low-sodium diet.They will also advise you to monitor your weight (weight gain of 1 to 1.5 kg) to detect possible fluid retention, as the effect of Loniten may be reduced.

Consult your doctor ifyou notice that your heart beats faster (tachycardia) or you experience chest pain or a feeling of oppression in the chest (angina pectoris). Minoxidil is usually administered with another blood pressure medication that prevents these symptoms.

During treatment, you may experience inflammation of the membrane that surrounds the heart (pericarditis) and/or accumulation of fluid in the interior of that membrane (pericardial effusion) that can compress the heart (cardiac tamponade).

In most patients treated with minoxidilexcessive hair growth (hypertrichosis) occurs. When treatment is stopped, the previous appearance usually recovers within1 to6 months.

If you are to undergo any diagnostic test (including blood tests and electrocardiograms) informyour doctorthat you are taking this medication, as it mayalter the 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 be treated with additional medications as decided by the specialist to prevent rapid heartbeats and fluid accumulation in the body. Consult with your doctor if the child experiences any of the following symptoms: very fast heart rate, rapid breathing, swelling in the legs, rapid weight gain, and reduced urine output. During treatment with minoxidil, the child will need to be seen by the doctor regularly.

Use of Loniten with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Especially, inform your doctor if you are taking other blood pressure medications. The concurrent use of minoxidil with some blood pressure medications (such as guanetidine and betanidine) may cause excessive lowering of blood pressure.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using this medication if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant.

Pregnancy

This medication is not recommended for pregnant women.

Excessive hair growth (hypertrichosis) has been reported in newborns of mothers who took Loniten during pregnancy.

Breastfeeding

The active ingredient of this medication passes into breast milk. Therefore, this medication is not recommended while breastfeeding, unless your doctor advises you to do so.

Fertility

This medication is not recommended for women of childbearing age who are not using reliable contraceptive methods.

Driving and operating machinery

No studies have been conducted on the effects of minoxidil on the ability to drive and operate machinery. Given that each individual's response to treatment may be different,avoid performing tasks that require special attentionuntil you check how you tolerate this medication.

Loniten contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Your doctor will decide what dose of minoxidil is most advisable for you. Do not take more tablets than specified by your doctor.

Take your minoxidil dose one or two times a day, as advised by your doctor.

The tablets of this medication can be swallowed whole with a little water.

Loniten is usually administered along with other medications that are also used for the treatment of high blood pressure that your doctor has prescribed for you.

Use inchildren and adolescents

The tablet can be divided intodosesequal.

Adult patients and those 12 years of age or older:

Normally, the initial dose of minoxidil for adults and children 12 years of age or older is 5 mg per day. Subsequently, the doctor may gradually increase the dose at intervals of at least 3 days between each dose change to reach the most appropriate dose. The maximum dose is 100 mg per day.

Patients 12 years of age or younger:

Treatment in children should always be done under strict surveillance. For patients 12 years of age or younger, the dose will depend on their body weight. As a guideline, the initial dose is 0.2 mg per kilogram of body weight per day. Subsequently, the doctor may gradually increase the dose at intervals of at least 3 days between each dose change to reach the most appropriate dose. The maximum dose is 50 mg per day.

If you take moreLonitenthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

A minoxidil overdose may cause excessive lowering of blood pressure.

If you forgot to take Loniten

Do not take a double dose to compensate for the missed doses.

If you forget to take a dose, take it as soon as you can. However, if it is almost time for the next dose, do not take the missed tablet.

If you interrupt treatment with Loniten

Do not stop taking the tablets of this medication unless your doctor tells you to, as this medication helps you control your blood pressure.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects that may occur include:

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

• rapid heartbeats (tachycardia), inflammation of the outer membrane that covers the heart (pericarditis)
• excessive hair growth (hirsutism), changes in hair color
• alterations in the electrocardiogram

Common side effects(affect up to 1 in 10 people):

• fluid retention, swelling caused by fluid accumulation (edema)
• fluid accumulation in the inner membranes that surround the heart (pericardial effusion) that may compress the heart (cardiac tamponade).
• digestive discomfort

Uncommon side effects(affect up to 1 in 100 people):

• fluid accumulation in the inner membranes that surround the lung (pleural effusion)
• breast tenderness

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

• low white blood cell count (leucopenia), low platelet count (thrombocytopenia)
• skin rash, blistering skin rash (dermatitis bullosa), generalized blistering rash with skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)

Side effects of unknown frequency:

• swelling of the extremities (peripheral edema), which may sometimes be accompanied by weight gain
• chest pain or pressure (angina pectoris)
• temporary elevation of certain substances in the blood (creatinine and urea) that may be observed in blood tests.
• severe skin disease characterized by the appearance of blisters and skin peeling (toxic epidermal necrolysis).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection pointofyour pharmacy. Incase of doubt, please ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Loniten

The active ingredient is minoxidil. Each tablet contains 10 mg of minoxidil.

The other components (excipients) are: microcrystalline cellulose, cornstarch, lactose monohydrate, colloidal silicon dioxide, and magnesium stearate.

Appearance of the product and contents of the packaging

White, round, biconvex tablets with the impression “10” on the un-scored face and a score on the opposite face, with the impressions “U” to one side of the score and “137” to the other side of the same.

The tablet can be divided into equal doses.

Loniten 10 mg tablets are presented in a PVC/aluminum blister. Each package contains 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Pfizer, S.L.

Avenida de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Responsible for manufacturing

Pfizer Service Company BV,

Hoge Wei 10

Zaventem, 1930

Belgium

This leaflet was approved in October 2015

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es