Patient leaflet - Prostap PD DCS 1.88 mg powder & solvent for prolonged-release suspension for injection in Pre-filled

1. WHAT PROSTAP PD DCS IS AND WHAT IT IS USED FOR

If you have a fatty liver.

In girls with central precocious puberty:

PROSTAP PD DCS is a synthetic hormone which can be used to reduce the levels of testosterone and oestrogen (sex steroids) circulating in the body.

After the first injection vaginal bleeding (spotting) and discharge may occur as a sign of hormone withdrawal. Vaginal bleeding beyond the first/second month of treatment needs to be investigated.

PROSTAP PD DCS is used to treat premature puberty which is caused by a release of certain hormones from the pituitary gland (central precocious puberty) in girls under 9 years of age and boys under 10 years of age with a body weight of less than 20 kg. Your doctor will make a precise diagnosis of central precocious puberty.

Discontinuation of treatment may lead to a slipping of the growth plate of the thigh bone. A possible cause could be a weakness of the growth plate due to a lower concentration of female sexual hormones during treatment.

Other medicines and PROSTAP PD DCS

2. WHAT YOU NEED TO KNOW BEFORE YOUR CHILD IS GIVEN PROSTAP PD DCS

Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding

Do not use PROSTAP PD DCS:

If your child is allergic (hypersensitive) to leuprorelin or any of the other ingredients of PROSTAP PD DCS (listed in section 6).
PROSTAP PD DCS must not be given to pregnant or breast-feeding girls (see also section “Do not use PROSTAP PD DCS’).
In girls with central precocious puberty
- if the girl to be treated is pregnant or breast-feeding.
  Driving and using machines
- if the girl has abnormal vaginal bleeding which has not been discussed with her doctor (see Warnings and Precautions section below).
  Your child may feel dizzy, have blurred vision or difficulty focussing his/her eyes. If these happen it may be dangerous to do things such as use machines, ride a bike or a horse or climb trees.

Warnings and Precautions:

When your child begins treatment with PROSTAP PD DCS, existing symptoms may initially get worse as a result of levels of sex steroids in the body increasing. These worsening symptoms usually subside with continued use of PROSTAP PD DCS (see section 4 for further information).

Severe skin rashes including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis (SJS/TEN) have been reported in association with leuprorelin. Stop using leuprorelin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

PROSTAP PD DCS contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per injection, that is to say it is essentially ‘sodium-free’.

3. HOW TO USE PROSTAP PD DCS

Your doctor or nurse will give your child an injection of PROSTAP PD DCS. The injection should be given immediately after it has been prepared. The injection will normally be given in the arm, thigh or abdomen. The injection site should be varied at regular intervals. Your child will normally be given an injection once a month.

The dosing scheme needs to be adapted individually.

The recommended starting dose is dependent on body weight:

a)
Children with a body weight less than 20 kg Taking into account the clinical activity of the central precocious puberty in these rare cases, the following applies:

Unless prescribed otherwise, 1 ml PROSTAP PD DCS (1.88 mg leuprorelin acetate) is administered once a month under the skin of e.g. abdomen, bottom or thigh as a single injection. Your doctor will monitor your child’s weight gain.

b) Children with a body weight 20 kg or more Other forms of leuprorelin may be more suitable, such as 1 ml PROSTAP SR (3.75 mg leuprorelin acetate) administered once a month under the skin. Depending on the central precocious puberty activity, your doctor may increase the dosage in the presence of inadequate suppression (e.g. vaginal bleeding). Your doctor will determine the minimal effective dose with the help of a blood test.

The duration of treatment depends on the clinical signs at the start of treatment or during the course of treatment and may be decided by your doctor together with the legal guardian and, if appropriate, child being treated. Your doctor will determine the bone age of your child at regular intervals.

In girls with bone age of older than 12 years and boys with bone age of older than 13 years your doctor will consider discontinuing the treatment, depending on the clinical effects.

In girls, pregnancy should be excluded before the start of treatment. The occurrence of pregnancy during treatment cannot be generally excluded. In such cases, please talk to your doctor.

The therapy is a long-term treatment, adjusted individually. Please arrange with your doctor that PROSTAP PD DCS is administered as precisely as possible in regular monthly periods. An exceptional delay of the injection date for a few days (30 ± 2 days) does not influence the result of the therapy. If you miss an injection

As soon as you realise your child has missed an injection, contact your doctor who will be able to give your child the next injection.

If you stop using PROSTAP PD DCS

Your doctor will talk to you and your child before stopping treatment.

Uncommon (may affect up to 1 in 100 people):

fatty liver
muscle ache

Very rare (may affect up to 1 in 10,000 people):

general allergic reactions (symptoms include fever, rash, itching, wheals or chills)
serious allergic reaction which causes difficulty in breathing or dizziness. If this happens, contact your doctor immediately or go to the hospital.
in patients with existing tumours of the pituitary gland, bleeding of the pituitary gland may occur. Not known (frequency cannot be estimated from the available data):
seizure
inflammation of lungs or lung disease
idiopathic intracranial hypertension (increased intracranial pressure around the brain characterised by headache, double vision and other visual symptoms and ringing or buzzing in one or both ears).
If you experience reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu- like symptoms (Stevens- Johnson syndrome/Toxic Epidermal Necrolysis).
Skin redness and itchy rash. (Toxic skin eruption) A skin reaction that causes red spots or patches on the skin, that may look like a target or "bulls-eye" with a dark red centre surrounded by paler red rings (Erythema Multiforme).

In general, if vaginal bleeding (spotting) occurs with continued treatment (after possible withdrawal bleeding in the first month of treatment), this may be a sign of potential underdosage. Please tell your doctor if vaginal bleeding occurs.

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 via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for 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.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, PROSTAP PD DCS can cause side effects, although not everybody gets them. Contact your doctor immediately or go to hospital:

If your child develops a severe rash, itching or shortness of breath or difficulty breathing. These could be symptoms of a severe allergic reaction. Tell your doctor:
If your child gets a severe headache which does not get better when they take painkillers.

At the beginning of treatment, a temporary rise in the sex hormone levels occurs, followed by a fall to values within the prepuberty range. Due to this effect, side effects may occur particularly at the start of treatment. Common (may affect up to 1 in 10 people):

mood swings
depression
headache
abdominal pain/abdominal cramps
feeling sick/vomiting
acne
vaginal bleeding
vaginal spotting
vaginal discharge
injection site reactions (these include hardening, redness, pain, abscesses, swelling, nodules, ulcers and skin damage)

5. HOW TO STORE PROSTAP PD DCS

Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.

Do not refrigerate or freeze.

Store in the original container in order to protect from light.

Once mixed with the Sterile Solvent, the suspension must be used immediately.

If the pack has been opened or damaged, return it to your pharmacist.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What PROSTAP PD DCS contains:

The active ingredient in PROSTAP PD DCS powder is leuprorelin acetate (1.88 mg).
The other ingredients in PROSTAP PD DCS powder are: copolymer (DL-lactic acid/glycolic acid)and mannitol (E421).
The Solvent contains carmellose sodium, mannitol (E421), polysorbate 80, water for injections and acetic acid, glacial.

PROSTAP

241113041147283

386234

160 x 600 (160x300)mm

N/A

9.00pt

United Kingdom (GBR)

Braille

Fonts

7885596 0 SP Helvetica Neue LT W1G, Praxis LT Pro, Frutiger LT Std No

12 May 2025

MySGS No:

Tech Spec Key

Novara

Markets

PROSTAP PD DCS should only be administered by your doctor or a nurse who will also take care of the preparation of the product.

PROSTAP PD DCS is a prolonged release powder for use in an injection.

The solventis a clear liquid, which is mixed with the PROSTAP PD DCS Powder before injection. Each pack contains a pre-filled dual chamber syringe containing 1.88 mg leuprorelin acetate powder in the front chamber and 1 ml of solvent in the rear chamber, a syringe needle fitted with a safety device and one syringe plunger.

Marketing Authorisation Holder:

Takeda UK Limited

1 Kingdom Street

London

W2 6BD

Manufacturer:

Delpharm Novara S.r.l.,

Via Crosa 86

28065 Cerano

Italy

This leaflet does not contain the complete information about your medicine. If you have any questions or you are not sure about anything you should ask your doctor or nurse who can give you more information. The information in this leaflet applies only to PROSTAP PD DCS. This leaflet was last revised in June 2025. * Registered Trademark of Takeda

This leaflet can be made available in large print, audio or Braille on request. Contact 0800 198 5000 to request this, quoting the following number: 16189/0038