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DALACIN T TOPICAL LOTION, CLINDAMYCIN 1%W/V TOPICAL LOTION - Patient leaflet, side effects, dosage

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Patient leaflet - DALACIN T TOPICAL LOTION, CLINDAMYCIN 1%W/V TOPICAL LOTION

Patient Information 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 your 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

0 What Dalacin T is and what it is used for

Q What you need to know before you use Dalacin T

Q How to use Dalacin T

0 Possible side effects

  • 0 How to store Dalacin T

  • 0 Contents of the pack and other information

Your medicine is called Dalacin T Topical Lotion but will be referred to as Dalacin T throughout the rest of this leaflet. Please note that the leaflet also contains information about the other medicine Dalacin T Topical Solution.

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Dalacin T Topical Lotion contains the active substance clindamycin phosphate. It is an anti-infective used on the skin for the treatment of acne in adults.

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Do not use Dalacin T:

  • if you are allergic to clindamycin, lincomycin or any of the other ingredients of this medicine (listed in section 6).

  • if you have a history of inflammatory bowel disease or antibiotic-associated colitis.

Warnings and precautions

Talk to your doctor or pharmacist before using Dalacin T if you have diarrhoea or usually get diarrhoea when you take antibiotics. If you develop severe or prolonged or bloody diarrhoea during or after using Dalacin T Lotion tell your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis ) which can occur following treatment with antibiotics.

Take care when using Dalacin T Topical Lotion around your mouth as it has an unpleasant taste.

Pregnancy and breast-feeding

Pregnancy

Dalacin T should be used during pregnancy only if clearly needed.

Breast-feeding

Tell your doctor if you will be breastfeeding while using Dalacin T as the active substance in this medicine may be passed into breast milk. Your doctor will decide if Dalacin T Topical Lotion is suitable for you. If you continue to take Dalacin T, you should stop breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

No effects on the ability to drive or use machines have been seen with Dalacin T.

Dalacin T Topical Lotion contains cetostearyl alcohol and methyl parahydroxyben­zoate

Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

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Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Usually, you should use this medicine twice a day. Shake the bottle well before use and wash the affected area before applying the lotion. Apply a thin film of the lotion to the affected area by gently rubbing it into your skin. You may use a cotton pad for this, or you can use your fingers.

Wash and dry your hands before and after using the lotion. The Dalacin T Lotion bottle has a dispensing cap. Always replace the cap after use.

If you forget to apply Dalacin T Topical Lotion

Do not worry if you miss one or two applications; just carry on as soon as you remember.

If you stop using Dalacin T Topical Lotion

Do not stop using Dalacin T as soon as your acne starts to get better. Ask your doctor when you should stop the treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Other medicines and Dalacin T

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor if you are using any skin treatments that contain benzoyl peroxide. These medicines should not be used at the same time as Dalacin T. If you are going to hospital for a surgical procedure, tell your doctor and/or anaesthetist if you are taking neuromuscular blocking agents (drugs that cause paralysis of muscle).


Patient Information Leaflet (continued)

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you develop severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is an uncommon side effect which may occur after treatment with antibiotics and can be a sign of serious bowel inflammation or pseudomembranous colitis.

Side effects that have been seen with Dalacin T are:

Very common: may affect more than 1 in 10 people

  • Skin irritation (may cause symptoms such as burning, itching, peeling), hives, dryness of skin,

  • Hives,

  • A disease of the sebaceous glands resulting in an oily coating, crusts, or scales on the skin (seborrhoea)

Uncommon: may affect up to 1 in 100 people

  • Gastrointestinal disorder (may cause symptoms such as diarrhoea, and nausea)

Frequency not known, but may also occur

  • Infection of the hair follicles in the skin (also known as folliculitis),

  • Stinging of the eye,

  • Pain in the eye,

  • Stomach ache,

  • * Inflammation of the skin caused by contact with irritants or allergens

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: yellowcard or search for the MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

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What Dalacin T contains

Each ml contains clindamycin phosphate equivalent to 10mg clindamycin. Also contains glycerol, sodium lauryl sarcosinate, stearic acid, tegin, cetostearyl alcohol, isostearyl alcohol, methylparaben and purified water.

What Dalacin T looks like and contents of the pack

Dalacin T is a white to off-white aqueous emulsion

Each bottle contains 30ml of Dalacin T Lotion

Manufacturer and Licence Holder

Manufactured by Pfizer Service Company bvba, Hoge Wei 10 1930 Zaventem Belgium and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

|POM PL 15184/1586 Dalacin T Topical Lotion

Dalacin is a registered trademark of Pfizer Enterprises Sarl.

Revision date: 09/03/2021

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet in a format suitable for you

0

Patient Information 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 your 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

0 What Clindamycin is and what it is used for

0 What you need to know before you use Clindamycin

Q How to use Clindamycin

0 Possible side effects

0 How to store Clindamycin

0 Contents of the pack and other information

Your medicine is called Clindamycin Topical Lotion but will be referred to as Clindamycin throughout the rest of this leaflet. Please note that the leaflet also contains information about the other medicine Clindamycin Topical Solution.

0

Clindamycin contains the active substance clindamycin phosphate. It is an anti-infective used on the skin for the treatment of acne in adults

0 What you need to know before you use Clindamycin

Do not use Clindamycin:

  • if you are allergic to clindamycin, lincomycin or to any of the other ingredients of this medicine (listed in section 6).

  • if you have a history of inflammatory bowel disease or antibiotic-associated colitis.

Warnings and precautions

Talk to your doctor or pharmacist before using Clindamycin if you have diarrhoea or usually get diarrhoea when you take antibiotics. If you develop severe or prolonged or bloody diarrhoea during or after using Clindamycin tell your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.

Take care when using Clindamycin lotion around your mouth as it has an unpleasent taste.

Other medicines and Clindamycin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are using any skin treatments that contain benzoyl peroxide. These medicines should not be used at the same time as Clindamycin lotion.

If you are going to hospital for a surgical procedure, tell your doctor and/or anaesthetist if you are taking neuromuscular blocking agents (drugs that cause paralysis of muscle).

Pregnancy and breast-feeding

Pregnancy

Clindamycinl Lotion should be used during pregnancy only if clearly needed.

Breast-feeding

Tell your doctor if you will be breastfeeding while using Clindamycinl Lotion as the active substance in this medicine may be passed into breast milk. Your doctor will decide if Clindamycinl Lotion is suitable for you. If you continue to take Clindamycinl Lotion, you should stop breast-feeding.

Driving and using machines

No effects on the ability to drive or use machines have been seen with Clindamycin.

Clindamycinl Lotion contains cetostearyl alcohol and methyl parahydroxyben­zoate

Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

0 How to use Clindamycin

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Usually, you should use this medicine twice a day. Shake the bottle well before use and wash the affected area before applying the lotion. Apply a thin film of the lotion to the affected area by gently rubbing it into your skin. You may use a cotton pad for this, or you can use your fingers.

Wash and dry your hands before and after using the lotion. The Clindamycin Lotion bottle has a dispensing cap.

Always replace the cap after use.

If you forget to apply Clindamycin

Do not worry if you miss one or two applications; just carry on as soon as you remember.

If you stop using Clindamycin

Do not stop using Clindamycin as soon as your acne starts to get better. Ask your doctor when you should stop the treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Patient Information Leaflet (continued)

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you develop severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is an uncommon side effect which may occur after treatment with antibiotics and can be a sign of serious bowel inflammation or pseudomembranous colitis.

Side effects that have been seen with Clindamycin Lotion are:

Very common: may affect more than 1 in 10 people

Skin irritation (may cause symptoms such as burning, itching, peeling), hives,dryness of skin

Hives,

  • A disease of the sebaceous glands resulting in an oily coating, crusts, or scales on the skin (seborrhoea)

Common: may affect up to 1 in 10 people

  • Oily skin

Uncommon: may affect up to 1 in 100 people (only seen with Clindamycin solution)

  • Gastrointestinal disturbances (may cause symptoms such as diarrhoea, and nausea)

Frequency not known, but may also occur

  • Severe acne (also known as gram-negative folliculitis), stinging in the eye, stomach pain, inflammation of the skin caused by contact with irritants or allergens

  • * Clindamycin lotion may cause gastrointestinal disturbances (with symptoms such as diarrhoea and nausea)

0

What Clindamycin contains

Each ml contains clindamycin phosphate equivalent to 10mg clindamycin. Also contains glycerol, sodium lauryl sarcosinate, stearic acid, tegin, cetostearyl alcohol, isostearyl alcohol, methylparaben and purified water.

What Clindamycin looks like and contents of the pack

Clindamycin is a white to off-white aqueous emulsion

Each bottle contains 30ml of Clindamycin Lotion

Manufacturer and Licence Holder

Manufactured by Pfizer Service Company bvba, Hoge Wei 10 1930 Zaventem Belgium and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

|POM PL 15184/1586 Clindamycin 1% w/v Topical Lotion

Revision date: 09/03/2021

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet in a format suitable for you

O

Keep out of the sight and reach of children.

Do not store above 25°C.

Replace cap tightly after use.

Do not use this lotion after the expiry date which is stated on the label or carton. The expiry date refers to the last day of the month.

If your doctor tells you to stop taking this medicine, return any unused capsules to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to.

If the lotion becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

Frequently Asked Questions

What is Dalacin T Topical Lotion used for?

Dalacin T Topical Lotion contains clindamycin, which is primarily used to treat acne by reducing inflammation and bacteria on the skin.

How should I apply Dalacin T Topical Lotion?

Apply a thin layer of Dalacin T Topical Lotion to the affected areas of your skin, usually once or twice a day as directed by your doctor.

Can I use Dalacin T with other acne treatments?

It’s best to consult with your healthcare provider before combining Dalacin T with other acne treatments to avoid irritation or adverse effects.

Is Dalacin T safe for all skin types?

Dalacin T is generally safe for most skin types, but individuals with sensitive skin should use it with caution and consult their doctor.

What should I do if I miss a dose of Dalacin T?

If you miss a dose, apply it as soon as you remember. If it's almost time for your next dose, skip the missed one and continue your regular schedule.

Can pregnant or breastfeeding women use Dalacin T?

Pregnant or breastfeeding women should consult their healthcare provider before using Dalacin T to discuss potential risks and benefits.

How long does it take to see results from Dalacin T Topical Lotion?

Many patients start to see improvements in their acne within 4-6 weeks, but full results may take several weeks of consistent use.

Are there any common side effects of using Dalacin T?

Common side effects may include dryness, redness, itching, or peeling at the application site. If these persist or worsen, contact your doctor.

Can I use makeup while using Dalacin T?

Yes, you can use makeup while using Dalacin T, but it’s advisable to let the lotion dry completely before applying makeup.

Should I wash my face before applying Dalacin T?

Yes, cleanse your face gently with a mild soap and pat dry before applying Dalacin T to ensure proper absorption.

What happens if I accidentally ingest Dalacin T Topical Lotion?

If ingested, seek medical attention immediately or contact a poison control center. Do not induce vomiting unless instructed by a professional.

Can I use sunscreen while using Dalacin T?

Yes, wearing sunscreen is recommended when using Dalacin T since some acne treatments can increase sensitivity to sunlight.

How should I store Dalacin T Topical Lotion?

Store Dalacin T at room temperature, away from direct light and moisture. Keep it out of reach of children.

What if my acne worsens after starting Dalacin T?

If your acne worsens after starting treatment with Dalacin T, contact your healthcare provider for guidance on how to proceed.

Is there anyone who should avoid using Dalacin T?

People with a history of allergic reactions to clindamycin or lincomycin should avoid using this product. Consult your doctor if unsure.

Can I stop using Dalacin T once my acne clears up?

It's advisable to continue using the medication as directed even after improvement to prevent future breakouts. Discuss with your provider for guidance.

Are there any dietary restrictions while using Dalacin T?

There are no specific dietary restrictions when using Dalacin T; however, maintaining a healthy diet can support overall skin health.

Does insurance typically cover the cost of Dalacin T Topical Lotion?

Insurance coverage may vary; check with your insurance provider for specific details regarding coverage for dermatological medications like Dalacin T.

What are the primary ingredients in Dalacin T Topical Lotion aside from clindamycin?

In addition to clindamycin phosphate, other ingredients may include alcohols and emollients that help in delivering the medication effectively.