Carexidil

Package leaflet: Information for the user

CAREXIDIL 5% cutaneous spray, solution

Minoxidil
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you notice worsening of symptoms.

Contents of this leaflet:

1. What CAREXIDIL is and what it is used for
2. What you need to know before using CAREXIDIL
3. How to use CAREXIDIL
4. Possible side effects
5. How to store CAREXIDIL
6. Contents of the pack and other information

1. What CAREXIDIL is and what it is used for

Carexidil is a solution intended for use on the scalp and contains a medicinal substance called minoxidil.
Carexidil is indicated for the treatment of certain types of hair loss (androgenetic alopecia), a condition
characterized by excessive hair loss due to the action of certain hormones present in the body
(androgenic hormones).
This condition manifests as follows:

• in women, as diffuse thinning of the hair affecting the upper part of the head, starting from the center;
• in men, as progressive hair loss in the frontal areas (receding hairline) and the upper part of the scalp (balding crown).

The onset and intensity of regrowth may vary from patient to patient. Since hair grows slowly, it may
take up to 4 months before the first results of treatment become noticeable. If you do not observe
any improvement after this period, consult your doctor.

2. What you need to know before using CAREXIDIL

Do not use Carexidil:

• if you are allergic to minoxidil or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from heart diseases (coronary heart disease, arrhythmias, congestive heart failure, or valvular heart disease);
• if you are pregnant or breastfeeding.

Warnings and precautions
Carexidil is not indicated under the following conditions:

• there is no family history of hair loss;
• your hair loss is sudden and/or patchy;
• hair loss has been present since birth (congenital alopecia);
• your hair loss is due to childbirth, toxic substances or medications, scarring (e.g. following trauma, infections, or psychological causes), or if the cause is unknown;
• you have red, inflamed, infected, or painful scalp.

During treatment with minoxidil:

• you may notice an increased hair shedding due to the action of minoxidil: old hairs fall out as new hairs grow in their place. This temporary increase in shedding usually occurs between the 2nd and 6th week after starting treatment and resolves within a couple of weeks. If shedding persists, discontinue use of Carexidil and consult your doctor.
• initially, regrowth consists of soft, weak hairs with a different color compared to your normal hair. With continued treatment, the new hairs will gradually acquire the same thickness and color as your natural hair. Results may be seen within 3–4 months. Treatment effectiveness varies from patient to patient.
• some patients have experienced changes in hair color or hair texture.

Transfer of the product to areas other than the scalp may cause unwanted hair growth.
If you do not notice any improvement after 4 months of treatment, contact your doctor.
Stop taking Carexidil and consult your doctor immediately if you notice:

• severe allergic reactions which may present as skin rashes, swelling of the hands, feet, face, eyes, lips, throat, with breathing difficulties (angioedema);
• low or high blood pressure (hypotension or hypertension), increased heart rate (tachycardia), sensation of pounding heartbeat (palpitations), chest pain (possible angina), weakness, dizziness;
• sudden and unexplained weight gain;
• persistent redness or irritation of the scalp (which may also occur due to sensitization from prolonged use of the medicine);
• any other unexpected new symptoms (see section 4. “Possible side effects”).

Special populations
The use of Carexidil is not recommended in patients over 55 years of age.
Children and adolescents
The use of Carexidil is not recommended in patients under 18 years of age.
Other medicines and Carexidil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are using medicines that dilate blood vessels (peripheral vasodilators).
Do not use Carexidil together with other medicines applied directly to the scalp (corticosteroids, tretinoin, anthralin).
Pregnancy, breastfeeding, and fertility
Do not use Carexidil if you are planning a pregnancy, during pregnancy, or while breastfeeding.
Driving and using machines
Based on the available knowledge about this medicine, no effects on the ability to drive or use machines are known.
However, during treatment with this medicine, you may experience certain side effects (including, for example, visual disturbances) that could impair your ability to drive or operate machinery. Exercise particular caution before driving or operating machinery if you experience these symptoms during treatment with this medicine.
Carexidil contains:

• Ethanol (alcohol): may cause burning and irritation to the eyes. In case of accidental contact with sensitive surfaces (eyes, abraded skin, or mucous membranes), rinse the area thoroughly with large amounts of fresh water.

3. How to use CAREXIDIL

Use this medicine exactly as stated in this leaflet or according to the instructions given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For external use only.

The recommended dose is 1 ml of cutaneous solution (corresponding to 10 sprays) applied twice daily to the scalp, preferably in the morning and evening.
The dose is independent of the size of the area to be treated.
The total daily dose must not exceed 2 ml. Using more product or using it more frequently does not improve results.

How to apply Carexidil
Apply Carexidil only to completely dry hair and scalp.
Begin application from the center of the area to be treated and spread the dose over all affected areas.
Do not apply Carexidil to other areas of the body. Avoid contact with the eyes. If contact occurs, rinse the affected area thoroughly with large amounts of fresh water.
After applying Carexidil, wash your hands carefully.

Instructions for use
Unscrew the white polypropylene cap. Attach the spray applicator to the bottle and screw it on tightly. Attach the extension piece onto the stem and press firmly to secure it. Direct the extension towards the area to be treated, spray once, and distribute Carexidil with the fingertips over the treated area. Repeat this procedure a total of 10 times to deliver a dose of 1 ml of solution. Avoid inhaling the spray mist.

Use in children and adolescents
The use of Carexidil is not recommended in individuals under 18 years of age.

If you use more Carexidil than you should
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.

Symptoms
If accidentally ingested orally or applied at doses higher than recommended on body areas other than the scalp, the product may cause:

• lowering of blood pressure (hypotension),
• increased heart rate (tachycardia),
• dizziness and weakness.

Treatment
The doctor will provide appropriate supportive therapy.

If you forget to use Carexidil
Do not use a double dose to make up for the missed dose. Resume treatment according to the instructions described in this patient information leaflet.

If you stop treatment with Carexidil, new hair growth will cease and pre-treatment symptoms will reappear within 3–4 months.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Carexidil may cause side effects, although not everyone gets them.
Stop taking Carexidil and contact your doctor immediately if you notice:

• severe allergic reactions which may present as skin rashes, swelling of the hands, feet, face, lips, throat, with breathing difficulties (angioedema);
• low blood pressure (hypotension), increased heart rate (tachycardia), sensation of pounding heartbeat (palpitations), chest pain (possible angina), weakness, dizziness;
• sudden and unexplained weight gain;
• persistent redness or irritation of the scalp.

The following side effects may occur:
Very common side effects (may affect more than 1 in 10 people)
Headache.
Common side effects (may affect up to 1 in 10 people)
Itching at the application site or throughout the body and of the eye, skin rash at the application site or throughout the body, increased hair growth (hypertrichosis), increased blood pressure (hypertension), peripheral edema, dyspnea (difficulty breathing), dermatitis, acneiform dermatitis, weight gain.
Uncommon side effects (may affect up to 1 in 100 people)
Low blood pressure, irritation, redness (erythema, generalized erythema), swelling (edema), skin peeling, eczema, allergic reaction, sensitization, urticaria, facial swelling, pain, dermatitis (including contact dermatitis, application site dermatitis, allergic, atopic and seborrheic dermatitis), dry skin (including dryness at the application site), blister formation, acne, weakness, dizziness, vertigo, tingling sensations, nerve inflammation (neuritis), taste disturbances, burning sensation, ear infection, external otitis, visual disturbances.
Rare side effects (may affect up to 1 in 1,000 people)
Sensation of pounding heartbeat (palpitations), increased heart rate (tachycardia), bleeding and ulcerations, blister formation, hair loss (alopecia) or worsening of hair loss, eye irritation, kidney stones, liver inflammation (hepatitis), sexual dysfunction.
Very rare side effects (may affect up to 1 in 10,000 people)
Chest pain, temporary hair loss, changes in hair color, abnormal hair structure, nausea, vomiting, angioedema, hypersensitivity, contact dermatitis.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CAREXIDIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The shelf life after first opening the container is 30 days under normal conditions of use.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Carexidil contains

• The active substance is minoxidil (50 mg in 1 ml of cutaneous solution).
• The other components are ethanol (96%), glycerol, butenedioic acid polymer with methoxyethylene, monobutyl ester and purified water.

Description of the appearance of Carexidil and the pack contents
Carexidil is a transparent, colourless or slightly yellowish cutaneous solution with an alcoholic odour.
Carexidil is available in a pack containing 1 high-density polyethylene bottle of 60 ml with a polypropylene cap. The bottle is equipped with a dosing pump.
Also available in packs containing: 2, 3 or 4 bottles of 60 ml.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Difa Cooper S.p.A.
Via Milano, 160
21042 Caronno Pertusella (VA)

Manufacturer
INDUSTRIAL FARMACÉUTICA CANTABRIA S.A.
Carretera de Cazoña-Adarzo, s/n
39011 Santander – Spain

Package leaflet: Information for the user

CAREXIDIL 2% cutaneous spray, solution

Minoxidil
Equivalent medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

1. What CAREXIDIL is and what it is used for
2. What you need to know before using CAREXIDIL
3. How to use CAREXIDIL
4. Possible side effects
5. How to store CAREXIDIL
6. Contents of the pack and other information

1. What CAREXIDIL is and what it is used for

Carexidil is a solution intended for use on the scalp and contains a medicinal substance called minoxidil.
Carexidil is indicated for the treatment of certain types of hair loss (androgenetic alopecia), a condition
characterized by excessive hair loss due to the action of certain hormones present in the body
(androgenic hormones).

This condition manifests as:

• diffuse thinning of hair in women, affecting the upper part of the head starting from the center;
• progressive hair loss in men in the frontal areas (receding hairline) and upper regions of the scalp (balding crown).

The onset and intensity of hair regrowth may vary from patient to patient. Since hair grows slowly, it may take up to 4 months before the first results of treatment become noticeable. If you do not observe any improvement after this period, consult your doctor.

2. What you should know before using CAREXIDIL

Do not use Carexidil:

• if you are allergic to minoxidil or to any of the other ingredients of this medicine (listed in section 6);
• if you have heart diseases (coronary heart disease, arrhythmias, congestive heart failure, or valvular heart disease);
• if you are pregnant or breastfeeding.

Warnings and precautions
Carexidil is not indicated in the following conditions:

• there is no family history of hair loss;
• your hair loss is sudden and/or patchy;
• hair loss has been present since birth (congenital alopecia);
• your hair loss is due to childbirth, toxic substances or medications, scarring (e.g., following trauma, infections, or psychological causes), or if the cause is unknown;
• you have a red, inflamed, infected, or painful scalp.

During treatment with minoxidil:

• you may notice an increased hair loss due to the action of minoxidil: old hairs fall out as new hairs grow in their place. This temporary increase in hair shedding usually occurs between the 2nd and 6th week after starting treatment and resolves within a couple of weeks. If hair loss persists, discontinue use of Carexidil and consult your doctor.
• initially, regrowth consists of soft, weak hairs with a different color compared to your normal hair. With continued treatment, "new hairs" will eventually have the same thickness and color as your natural hair. Results may be visible within less than 3–4 months. The effectiveness of treatment varies from patient to patient.
• some patients have experienced changes in hair color or hair texture.

Transfer of the product to areas other than the scalp may cause unwanted hair growth.
If you do not notice any improvement after 4 months of treatment, contact your doctor.
Stop taking Carexidil and consult your doctor immediately if you notice:

• severe allergic reactions which may present as skin rashes, swelling of the hands, feet, face, eyes, lips, throat, with breathing difficulties (angioedema);
• low or high blood pressure (hypotension or hypertension), rapid heartbeat (tachycardia), sensation of pounding heartbeat (palpitations), chest pain (possible angina), weakness, dizziness;
• sudden and unexplained weight gain;
• persistent redness or irritation of the scalp (which may also occur due to sensitization from prolonged use of the medicine);
• any other new unexpected symptoms (See section 4. “Possible side effects”).

Special populations
The use of Carexidil is not recommended in patients over 55 years of age.
Children and adolescents
The use of Carexidil is not recommended in patients under 18 years of age.
Other medicines and Carexidil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are using medicines that dilate blood vessels (peripheral vasodilators).
Do not use Carexidil together with other medicines applied directly to the scalp (corticosteroids, tretinoin, anthralin).
Pregnancy, breastfeeding and fertility
Do not use Carexidil if you are planning a pregnancy, during pregnancy, or while breastfeeding.
Driving and use of machines:
Based on the available knowledge about this medicine, no effects on the ability to drive or operate machinery are known.
However, during treatment with this medicine, you may experience certain side effects (including, for example, visual disturbances) that could impair your ability to drive vehicles or operate machinery. Exercise particular caution before driving or operating machinery if you experience these symptoms during treatment with this medicine.
Carexidil contains:

• propylene glycol: may cause skin irritation;
• ethanol (ethyl alcohol): may cause burning and irritation to the eyes. In case of accidental contact with sensitive surfaces (eyes, abraded skin, and mucous membranes), rinse the area thoroughly with large amounts of fresh water.

3. How to use Carexidil

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For external use only.

The recommended dose is 1 ml of cutaneous solution (corresponding to 10 sprays) applied twice daily to the scalp, preferably in the morning and evening.
The dose is independent of the size of the area to be treated.
The total daily dose must not exceed 2 ml. Using more product or using it more frequently does not improve results.

How to apply Carexidil
Apply Carexidil only to completely dry hair and scalp.
Begin application from the center of the area to be treated and spread the dose evenly over all affected areas.
Do not apply Carexidil to other areas of the body. Avoid contact with the eyes. If contact occurs, rinse the affected area thoroughly with large amounts of fresh water.
After applying Carexidil, wash your hands carefully.

Instructions for use
Unscrew the white polypropylene cap. Attach the spray applicator to the bottle and screw it on firmly. Attach the extender to the stem and press to secure it firmly. Direct the extender toward the area to be treated, spray once, and spread Carexidil over the treatment area using the fingertips. Repeat this procedure a total of 10 times to deliver a dose of 1 ml of solution. Avoid inhaling the vapors.

Use in children and adolescents
The use of Carexidil is not recommended in individuals under 18 years of age.

If you use more Carexidil than you should
If an excessive dose of Carexidil is accidentally ingested or swallowed, contact your doctor immediately or go to the nearest hospital.

Symptoms
If the product is accidentally ingested orally or applied in doses higher than recommended to areas of the body other than the scalp, it may cause:

• lowering of blood pressure (hypotension),
• increased heart rate (tachycardia),
• dizziness and weakness.

Treatment
The doctor will provide appropriate supportive therapy.

If you forget to use Carexidil
Do not use a double dose to make up for the missed dose. Resume treatment according to the instructions described in this leaflet.

If you stop treatment with Carexidil, new hair growth will cease and pre-treatment symptoms will reappear within 3–4 months.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Carexidil may cause side effects, although not everyone experiences them.
Stop taking Carexidil and consult your doctor immediately if you notice:

• severe allergic reactions which may present as skin rashes, swelling of the hands, feet, face, lips, throat, with difficulty breathing (angioedema);
• low blood pressure (hypotension), increased heart rate (tachycardia), sensation of pounding heartbeat (palpitations), chest pain (possible angina), weakness, dizziness;
• sudden and unexplained weight gain;
• persistent redness or irritation of the scalp.

The side effects that may occur are listed below:

Very common side effects (may affect more than 1 in 10 people)
Headache.
Common side effects (may affect up to 1 in 10 people)
Itching at the application site or throughout the body and of the eye, skin rashes at the application site or throughout the body, increased hair growth (hypertrichosis), increased blood pressure (hypertension), peripheral edema, dyspnea (difficulty breathing), dermatitis, acneiform dermatitis, weight gain.
Uncommon side effects (may affect up to 1 in 100 people)
Low blood pressure, irritation, redness (erythema, generalized erythema), swelling (edema), skin desquamation, eczema, allergic reaction, sensitization, urticaria, facial swelling, pain, dermatitis (including contact dermatitis, application site dermatitis, allergic, atopic and seborrheic dermatitis), dry skin (including dryness at the application site), blister formation, acne, weakness, dizziness, vertigo, tingling sensations, nerve inflammation (neuritis), taste disturbances, burning sensation, ear infection, external otitis, visual disturbances.
Rare side effects (may affect up to 1 in 1,000 people)
Sensation of pounding heartbeat (palpitations), increased heart rate (tachycardia), bleeding and ulcerations, blister formation, hair loss (alopecia) or worsening of hair loss, eye irritation, kidney stones, liver inflammation (hepatitis), sexual dysfunction.
Very rare side effects (may affect up to 1 in 10,000 people)
Chest pain, temporary hair loss, changes in hair color, abnormal hair structure, nausea, vomiting, angioedema, hypersensitivity, contact dermatitis.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CAREXIDIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The shelf life after first opening the container is 30 days under normal conditions of use.
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 Carexidil contains

• The active substance is minoxidil (20 mg in 1 ml of topical solution).
• The other components are ethanol 96%, propylene glycol, purified water.

Description of the appearance of Carexidil and the contents of the pack
Carexidil is a clear, colourless or slightly yellowish topical solution with an alcoholic odour.
Carexidil is available in a pack containing one 60 ml high-density polyethylene bottle with a polypropylene cap.
The bottle is equipped with a dosing pump.
Also available in packs containing: 2, 3 or 4 bottles of 60 ml. Not all pack sizes may be marketed.

Marketing Authorization Holder
Difa Cooper S.p.A.
Via Milano, 160
21042 Caronno Pertusella (VA), Italy

Manufacturer
INDUSTRIAL FARMACÉUTICA CANTABRIA S.A.
Carretera de Cazoña-Adarzo, s/n
39011 Santander - Spain