LONITEN 10 mg tablets

2. What you need to know before taking Loniten

Do not take Loniten:

Warnings and precautions

Consult your doctor before starting to take 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 your treatment with a reduced dose once a day and gradually increase it until the effective dose is reached
• you have had a heart attack

Be careful with this medication if, during treatment, you notice that your limbs are swelling 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 instruct you to take Loniten along with another medication to lower blood pressure that promotes fluid elimination (diuretics). It is essential that you follow your doctor's instructions for taking this medication and their recommendations on a salt-free diet. They will also advise you to monitor your weight (an increase of 1 to 1.5 kg) to detect possible fluid retention, as the effect of Loniten may be reduced.

Consult your doctor if, during treatment, you notice that your heart is beating faster (tachycardia) or you experience pain or a feeling of pressure in your chest (angina pectoris). Minoxidil is usually administered along with another medication to lower blood pressure that prevents these symptoms.

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

In most patients treated with minoxidil, excessive body hair growth (hypertrichosis) occurs. When treatment is discontinued, the appearance usually returns to normal within 1 to 6 months.

If you are going to undergo any diagnostic tests (including blood tests and electrocardiograms), inform your doctor that you are taking this medication, as it may alter 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 can be adjusted according to the child's needs. During treatment, the child will also be treated with other medications as decided by the specialist to prevent rapid heartbeats and fluid accumulation in the body. You should consult with the doctor if the child has any of the following symptoms: very rapid heartbeat, 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 recently used, or may need to use any other medication.

Especially, inform your doctor if you are taking other medications to lower blood pressure. The concurrent use of minoxidil with some blood pressure medications (such as guanethidine and betanidine) can cause an excessive drop in blood pressure.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

The use of this medication is not recommended for pregnant women.

Excessive body 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, it is not recommended to take this medication 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 measures.

Driving and using machines

No studies have been conducted on the effects of minoxidil on the ability to drive and use machines. Since the response to treatment can vary from person to person, avoid performing tasks that require special attention until you know how you tolerate this medication.

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

3. How to take Loniten

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor again.

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

Take your dose of minoxidil once or twice a day, as advised by your doctor.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone experiences them.

The adverse effects that may occur include:

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

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

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

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

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

• fluid accumulation in the interior of the membranes that surround the lungs (pleural effusion)
• breast tenderness

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

• low white blood cell count (leukopenia), low platelet count (thrombocytopenia)
• skin rash, blistering skin 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 be accompanied by weight gain
• chest pain or pressure (angina pectoris)
• temporary elevation of certain blood substances (creatinine and urea) that may be observed in blood tests
• a severe skin disease characterized by the appearance of blisters and skin peeling (toxic epidermal necrolysis)

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Loniten

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

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

Do not store above 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

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 package contents

White, round, biconvex tablets with the imprint "10" on the non-scored face and on the opposite face scored, with the imprints "U" on one side of the score and "137" on the other side of the score.

The tablet can be divided into equal doses.