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IVERMECTIN 10 MG/G CREAM

Active substance(s): IVERMECTIN / IVERMECTIN

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Package leaflet: Information for the patient

Soolantra® 10 mg/g cream
(ivermectin)
This product is available using above name but will be referred to as Soolantra throughout the following leaflet.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, ask your doctor or pharmacist.
− This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same
as yours.
− If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Soolantra is and what it is used for
2. What you need to know before you use Soolantra
3. How to use Soolantra
4. Possible side effects
5. How to store Soolantra
6. Contents of the pack and other information

1. What Soolantra is and what it is used for
Soolantra contains the active substance ivermectin that belongs to a group of medicines called avermectins. The cream is used on the skin
to treat pimples and spots found with rosacea.
Soolantra should be used in adults only (18 years of age or older).

2. What you need to know before you use Soolantra
Do not use Soolantra:
− if you are allergic to ivermectin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Soolantra.
Other medicines and Soolantra
Other medicines may have an effect on Soolantra, you should therefore tell your doctor if you are using, have recently used or might use
any other medicines.
Pregnancy and breast-feeding
Soolantra is not recommended during pregnancy. If you are breast-feeding, you should not use this medicine, alternatively, you should stop
breast-feeding before starting treatment with Soolantra.
You should consult your doctor to help you decide between using Soolantra and breast-feeding, taking into account the benefit of the
treatment and the benefit of breast-feeding.
Driving and using machines
Soolantra has no or negligible influence on the ability to drive and use machines.
Soolantra contains:
− Cetyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis),
− Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed),
− Propylene glycol which may cause skin irritation.

3. How to use Soolantra
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Important: Soolantra is intended for adults and only for use on the skin of the face. Do not use this medicine on other parts of your body,
especially not moist body surfaces, e.g. your eyes, your mouth or any mucosa. Do not swallow.
The recommended dose is one application on facial skin per day. Apply a pea size amount of the cream to each of the five areas of the
face: forehead, chin, nose and each cheek. Then spread the cream as a thin layer across the entire face.
Make sure to avoid the eyelids, lips and any mucosa such as inside the nose, the mouth and the eyes. If you accidentally get cream in the
eyes or near the eyes, eyelids, lips, mouth or mucosa wash the area immediately with plenty of water.
Do not apply cosmetics (such as other facial creams or make-up) before the daily application of Soolantra. These products can be used
after the applied cream has dried.
Wash your hands immediately after applying the cream.
You should use Soolantra daily over the treatment course and the treatment course may be repeated. Your doctor will tell you how long you
will need to use Soolantra. The duration of treatment can vary from person to person and depends on the severity of the skin disorder. You
may notice an improvement after 4 weeks of treatment. In case of no improvement after 3 months, you should discontinue Soolantra and
consult your doctor.
Hepatic impairment
If you have liver problems, please consult your doctor before using Soolantra.
Use in children and adolescents
Soolantra should not be used by children and adolescents.
How to open the tube with child resistant cap
To avoid spilling, do not squeeze the tube while opening or closing.

Push down on the cap and turn counter clockwise (turn to the left). Then pull the cap off.

How to close the tube with a child resistant cap
Push down and turn clockwise (turn to the right).

If you use more Soolantra than you should
If you use more than the daily recommended dose, please contact your doctor, who will advise you on what action to take.
If you forget to use Soolantra
Do not use a double dose to make up for a forgotten dose.
If you stop using Soolantra
Pimples and spots will be reduced only after several applications of this medicine. It is important that you continue using Soolantra as long
as prescribed by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Soolantra may cause the following side effects:
Common side effect (may affect up to 1 in 10 people):
− Burning feeling of the skin
Uncommon side effects (may affect up to 1 in 100 people):
− Irritation of the skin
− Itching of the skin
− Dry skin
Not known side effect (frequency cannot be estimated from the available data)
− Redness of the skin
− Inflammation of the skin
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also
report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard

5. How to store Soolantra
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. The expiry date refers to the last day of that
month.
After first opening of the tube, use the product within 6 months.
This medicine does not require any special storage conditions.
Do not throw away unused Soolantra via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer
use. These measures will help protect the environment.
If your medicine become discoloured or show signs of any deterioration, consult your doctor or pharmacist who will tell you what to do.

6. Contents of the pack and other information
What Soolantra contains
− The active substance is ivermectin. One gram of cream contains 10 mg of ivermectin.
− The other ingredients are glycerol, isopropyl palmitate, carbomer, dimeticone, disodium edetate, citric acid monohydrate, cetyl alcohol,
stearyl alcohol, macrogol cetostearyl ether, sorbitan stearate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216),
phenoxyethanol, propylene glycol, oleyl alcohol, sodium hydroxide solution (10%) and purified water.
What Soolantra looks like and contents of the pack
Soolantra is a white to pale yellow cream. It is supplied in a tube with a child resistant closure.
Each pack contains 1 tube of 30 g.
PL: 27777/0030

POM

Manufactured by Laboratoire GALDERMA, Zone Industrielle de, Montdesir, 74540 Alby-sur-Cheran, France.
Procured from within the EU by the Product Licence holder: Vital Supplies (UK) Ltd., Unit 9, Enterprise Court, Eastways Industrial Estate,
Witham, CM8 2TJ, United Kingdom. Repackaged by O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet issue and revision (Ref.) 11.07.2017.
Soolantra is a registered trademark of Nestle Skin Health S.A.

To request a copy of this leaflet in Braille, large print or audio please call
01923 332 796.

Package leaflet: Information for the patient

Ivermectin 10 mg/g cream
This product is available using above name but will be referred to as Ivermectin cream throughout the following leaflet.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, ask your doctor or pharmacist.
− This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same
as yours.
− If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Ivermectin cream is and what it is used for
2. What you need to know before you use Ivermectin cream
3. How to use Ivermectin cream
4. Possible side effects
5. How to store Ivermectin cream
6. Contents of the pack and other information

1. What Ivermectin cream is and what it is used for
Ivermectin cream contains the active substance ivermectin that belongs to a group of medicines called avermectins. The cream is used on
the skin to treat pimples and spots found with rosacea.
Ivermectin cream should be used in adults only (18 years of age or older).

2. What you need to know before you use Ivermectin cream
Do not use Ivermectin cream:
− if you are allergic to ivermectin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Ivermectin cream.
Other medicines and Ivermectin cream
Other medicines may have an effect on Ivermectin cream, you should therefore tell your doctor if you are using, have recently used or
might use any other medicines.
Pregnancy and breast-feeding
Ivermectin cream is not recommended during pregnancy. If you are breast-feeding, you should not use this medicine, alternatively, you
should stop breast-feeding before starting treatment with Ivermectin cream.
You should consult your doctor to help you decide between using Ivermectin cream and breast-feeding, taking into account the benefit of
the treatment and the benefit of breast-feeding.
Driving and using machines
Ivermectin cream has no or negligible influence on the ability to drive and use machines.
Ivermectin cream contains:
− Cetyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis),
− Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed),
− Propylene glycol which may cause skin irritation.

3. How to use Ivermectin cream
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Important: Ivermectin cream is intended for adults and only for use on the skin of the face. Do not use this medicine on other parts of your
body, especially not moist body surfaces, e.g. your eyes, your mouth or any mucosa. Do not swallow.
The recommended dose is one application on facial skin per day. Apply a pea size amount of the cream to each of the five areas of the
face: forehead, chin, nose and each cheek. Then spread the cream as a thin layer across the entire face.
Make sure to avoid the eyelids, lips and any mucosa such as inside the nose, the mouth and the eyes. If you accidentally get cream in the
eyes or near the eyes, eyelids, lips, mouth or mucosa wash the area immediately with plenty of water.
Do not apply cosmetics (such as other facial creams or make-up) before the daily application of Ivermectin cream. These products can be
used after the applied cream has dried.
Wash your hands immediately after applying the cream.
You should use Ivermectin cream daily over the treatment course and the treatment course may be repeated. Your doctor will tell you how
long you will need to use Ivermectin cream. The duration of treatment can vary from person to person and depends on the severity of the
skin disorder. You may notice an improvement after 4 weeks of treatment. In case of no improvement after 3 months, you should
discontinue Ivermectin cream and consult your doctor.
Hepatic impairment
If you have liver problems, please consult your doctor before using Ivermectin cream.
Use in children and adolescents
Ivermectin cream should not be used by children and adolescents.
How to open the tube with child resistant cap
To avoid spilling, do not squeeze the tube while opening or closing.

Push down on the cap and turn counter clockwise (turn to the left). Then pull the cap off.

How to close the tube with a child resistant cap
Push down and turn clockwise (turn to the right).

If you use more Ivermectin cream than you should
If you use more than the daily recommended dose, please contact your doctor, who will advise you on what action to take.
If you forget to use Ivermectin cream
Do not use a double dose to make up for a forgotten dose.
If you stop using Ivermectin cream
Pimples and spots will be reduced only after several applications of this medicine. It is important that you continue using Ivermectin cream
as long as prescribed by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Ivermectin cream may cause the following side effects:
Common side effect (may affect up to 1 in 10 people):
− Burning feeling of the skin
Uncommon side effects (may affect up to 1 in 100 people):
− Irritation of the skin
− Itching of the skin
− Dry skin
Not known side effect (frequency cannot be estimated from the available data)
− Redness of the skin
− Inflammation of the skin
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also
report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard

5. How to store Ivermectin cream
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. The expiry date refers to the last day of that
month.
After first opening of the tube, use the product within 6 months.
This medicine does not require any special storage conditions.
Do not throw away unused Ivermectin cream via wastewater or household waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the environment.
If your medicine become discoloured or show signs of any deterioration, consult your doctor or pharmacist who will tell you what to do.

6. Contents of the pack and other information
What Ivermectin cream contains
− The active substance is ivermectin. One gram of cream contains 10 mg of ivermectin.
− The other ingredients are glycerol, isopropyl palmitate, carbomer, dimeticone, disodium edetate, citric acid monohydrate, cetyl alcohol,
stearyl alcohol, macrogol cetostearyl ether, sorbitan stearate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216),
phenoxyethanol, propylene glycol, oleyl alcohol, sodium hydroxide solution (10%) and purified water.
What Ivermectin cream looks like and contents of the pack
Ivermectin cream is a white to pale yellow cream. It is supplied in a tube with a child resistant closure.
Each pack contains 1 tube of 30 g.
PL: 27777/0030

POM

Manufactured by Laboratoire GALDERMA, Zone Industrielle de, Montdesir, 74540 Alby-sur-Cheran, France.
Procured from within the EU by the Product Licence holder: Vital Supplies (UK) Ltd., Unit 9, Enterprise Court, Eastways Industrial Estate,
Witham, CM8 2TJ, United Kingdom. Repackaged by O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet issue and revision (Ref.) 11.07.2017.

To request a copy of this leaflet in Braille, large print or audio please call
01923 332 796.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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