SUGAMMADEX DR. REDDYS 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Sugammadex Dr. Reddys 100 mg/ml solution for injection EFG

Read all of this leaflet carefully before you are given 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 anesthesiologist (anesthetist) or your doctor.
• If you experience any side effects, talk to your anesthesiologist or another doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sugammadex Dr. Reddys and what is it used for
2. What you need to know before you start using Sugammadex Dr. Reddys
3. How Sugammadex Dr. Reddys is administered
4. Possible side effects
5. Storage of Sugammadex Dr. Reddys
6. Package contents and further information

1. What is Sugammadex Dr. Reddys and what is it used for

What is Sugammadex Dr. Reddys

This medicine contains the active substance sugammadex. Sugammadex is considered a Selective Relaxant Binding Agentas it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.

What Sugammadex Dr. Reddys is used for

If you need to undergo surgery, your muscles must be completely relaxed, making it easier for the surgeon to perform the operation. For this, you will be given medications during general anesthesia to relax your muscles. These are called muscle relaxants, such as rocuronium bromide and vecuronium bromide. Since these medications also block the respiratory muscles, you will need help breathing (artificial respiration) during and after surgery until you can breathe on your own again.

Sugammadex is used to accelerate muscle recovery after surgery so that you can breathe on your own again sooner. It does this by combining with rocuronium bromide or vecuronium bromide in your body. It can be used in adults when rocuronium bromide or vecuronium bromide is used and in children and adolescents (between 2 and 17 years) when rocuronium bromide is used for moderate muscle relaxation.

2. What you need to know before you start using Sugammadex Dr. Reddys

You must not be given Sugammadex Dr. Reddys

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

→ Tell your anesthesiologist if this applies to you.

Warnings and precautions

Talk to your anesthesiologist before you start using Sugammadex Dr. Reddys

• if you have any kidney disease or have had it in the past. This is important because sugammadex is eliminated from your body by the kidneys.
• if you have liver disease or have had it before.
• if you have fluid retention (edema).
• if you have a disease that increases the risk of bleeding (blood coagulation disorders) or if you are taking anticoagulant medication.

Children and adolescents

This medicine is not recommended for children under 2 years of age.

Other medicines and Sugammadex Dr. Reddys

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

Sugammadex may affect other medicines or be affected by them.

Some medicines reduce the effect of Sugammadex Dr. Reddys

→It is especially important that you tell your anesthesiologist if you have recently taken:

• toremifene (used to treat breast cancer).
• fusidic acid (an antibiotic).

Sugammadex Dr. Reddys may affect hormonal contraceptives

• Sugammadex may make hormonal contraceptives - such as the "Pill", vaginal ring, implants, or an Intrauterine Hormonal Device (IUD) - less effective because it reduces the amount of progestogen that reaches you. The amount of progestogen lost due to the use of sugammadex is approximately the same as when you miss a birth control pill.

→ If you are taking the Pillon the same day that you are given sugammadex, follow the instructions for missing a pill in the package leaflet of your pill.

→ If you are using otherhormonal contraceptives (e.g., vaginal ring, implant, or IUD), you should use a non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the recommendations in the package leaflet.

Effects on blood tests

In general, sugammadex does not affect laboratory tests. However, it may affect the results of a blood test when progesterone levels are measured. Talk to your doctor if your progesterone levels need to be analyzed on the same day you receive sugammadex.

Pregnancy and breastfeeding

→Tell your anesthesiologist if you are pregnant or might be pregnant or if you are breastfeeding.

It is possible that you will still be given sugammadex, but it needs to be discussed beforehand.

It is not known if sugammadex can pass into breast milk. Your anesthesiologist will help you decide whether to interrupt breastfeeding or avoid treatment with sugammadex, considering the benefit of breastfeeding for the baby and the benefit of sugammadex for the mother.

Driving and using machines

Sugammadex has no known influence on the ability to drive and use machines.

Sugammadex Dr. Reddys contains sodium

This medicine contains up to 9.7 mg of sodium (a major component of table salt/cooking salt) per ml. This is equivalent to 0.5% of the maximum daily sodium intake recommended for an adult.

3. How Sugammadex Dr. Reddys is administered

Sugammadex will be administered to you by your anesthesiologist or under their supervision.

Dose

Your anesthesiologist will calculate the dose of sugammadex you need based on:

• your weight
• the amount of muscle relaxant that is still affecting you.

The usual dose is 2-4 mg per kg of body weight for adults and for children and adolescents from 2 to 17 years. A dose of 16 mg/kg can be used in adults if urgent recovery of muscle relaxation is needed.

The dose of sugammadex for children is 2 mg/kg (children and adolescents between 2-17 years).

How Sugammadex Dr. Reddys is administered

Sugammadex will be administered to you by your anesthesiologist. It is injected once intravenously.

If you are given more Sugammadex Dr. Reddys than recommended

Since your anesthesiologist will be carefully monitoring the situation, it is unlikely that you will be given too much sugammadex. But even if this happens, it is unlikely to cause any problems.

If you have any further questions about the use of this medicine, ask your anesthesiologist or another doctor.

4. Possible side effects

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

If these side effects occur while you are under anesthesia, your anesthesiologist will detect and treat them.

Common (may affect up to 1 in 10 people)

• Cough
• Respiratory difficulties that may include cough or movements as if waking up or taking a breath
• Light anesthesia – you may start to wake up, so you may need more anesthetic. This can cause you to move or cough at the end of the operation
• Complications during the procedure, such as changes in heart rate, cough, or movement
• Decrease in blood pressure due to surgery

Uncommon (may affect up to 1 in 100 people)

• Difficulty breathing due to muscle spasms in the airways (bronchospasm) that occur in patients with a history of lung problems
• Allergic reactions (hypersensitivity to medicines) - such as rash, skin redness, swelling of your tongue and/or pharynx, difficulty breathing, changes in blood pressure or heart rate, which sometimes result in a severe drop in blood pressure. Allergic reactions or severe allergic reactions can be life-threatening

Allergic reactions were reported more frequently in healthy conscious volunteers

• Reappearance of muscle relaxation after surgery

Frequency not known

• When Sugammadex Dr. Reddys is administered, a significant slowing of the heart can occur, which can even lead to cardiac arrest

Reporting of side effects

If you experience any side effects, talk to your anesthesiologist, another doctor, or your pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Dr. Reddys

Storage will be the responsibility of healthcare professionals.

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 on the label after “EXP”. The expiry date is the last day of the month shown.

Do not freeze. Store the vial in the outer packaging to protect it from light.

After opening and dilution, store at 2-8°C and use within 24 hours.

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

6. Package contents and further information

Composition of Sugammadex Dr. Reddys

• The active substance is sugammadex.

1 ml of solution for injection contains sugammadex sodium equivalent to 100 mg of sugammadex.

Each 2 ml vial contains sugammadex sodium equivalent to 200 mg of sugammadex.

Each 5 ml vial contains sugammadex sodium equivalent to 500 mg of sugammadex.

The other ingredients are water for injections and for pH adjustment: sodium hydroxide 0.04% and hydrochloric acid 0.3%.

Appearance and package contents

Sugammadex Dr. Reddys is a clear, colorless to slightly yellowish solution for injection.

Package sizes:

1 vial of 2 ml

10 vials of 2 ml

1 vial of 5 ml

10 vials of 5 ml

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona (Spain)

Phone: 93.355.49.16

Fax: 93.355.49.61

Manufacturer

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg,

Germany

or

Dr. Reddy’s Laboratories România S.R.L.

Str. Daniel Danielopolu, nr.30 - 32, Spatiul 2

Etaj 5, Sectorul 1,

Bucharest, postal code 014134,

Romania

or

SC Rual Laboratories SRL

313, Splaiul Unirii, Building H, 1st floor, sector 3,

030138 Bucharest,

Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:August 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)