Label: information for the user

Sugammadex Dr. Reddys 100 mg/ml injectable solution EFG

Read this label carefully before this medicine is administered to you, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your anesthesiologist (anesthetist) or doctor.
• If you experience any adverse effects, consult your anesthesiologist or another doctor, even if they are not listed in this label. See section 4.

Label content

1. What Sugammadex Dr. Reddys is and for what it is used
2. What you need to know before starting the administration of Sugammadex Dr. Reddys
3. How to administer Sugammadex Dr. Reddys
4. Possible adverse effects
5. Storage of Sugammadex Dr. Reddys
6. Contents of the package and additional information

What is Sugammadex Dr. Reddys

This medication contains the active ingredient sugammadex. Sugammadex is considered aSelective Muscle Relaxant Agentas it only works with specific muscle relaxants, bromide of rocuronium or bromide of vecuronium.

For what Sugammadex Dr. Reddys is used

If you have to operate, your muscles must be completely relaxed, which facilitates the surgeon's operation. For this, during general anesthesia, they will give you medications to relax your muscles. They are calledmuscle relaxants, and for example, they are bromide of rocuronium and bromide of vecuronium. As those medications also block the muscles of breathing, you will need help to breathe (artificial respiration) during and after your operation until you can breathe again on your own.

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

Do not receive Sugammadex Dr. Reddys

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

→ Inform your anesthesiologist if this is the case.

Warnings and precautions

Consult your anesthesiologist before starting the administration of 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 previously.
• if you have fluid retention (edema).
• if you have a disease that increases the risk of bleeding (blood clotting disorders) or are taking anticoagulant medication.

Children and adolescents

This medication is not recommended for children under 2 years.

Other medications and Sugammadex Dr. Reddys

→ Inform your anesthesiologist if you are taking, have taken recently, or may need to take any other medication.

Sugammadex may affect other medications or be affected by them.

Some medications reduce the effect of Sugammadex Dr. Reddys

→It is especially important to inform your anesthesiologist if you have taken recently:

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

Sugammadex Dr. Reddys may affect hormonal contraceptives

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

→ If you are taking The Pill on the same day that sugammadex is administered, follow the instructions in case of missing a pill from the Pill prospectus.

→ If you are using other hormonal contraceptives (for example vaginal ring, implant, or IUD-h) you should use a non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the recommendations in the prospectus.

Effects on blood tests

In general, sugammadex has no effects on laboratory tests. However, it may affect the results of a blood test when measuring progesterone hormone levels. Consult your doctor if your progesterone levels need to be analyzed on the same day you receive sugammadex.

Pregnancy and breastfeeding

→Inform your anesthesiologist if you are pregnant or may be pregnant or if you are breastfeeding.

It is possible that sugammadex will still be administered, but it is necessary to discuss it beforehand.

No information is known about whether sugammadex can pass into breast milk. Your anesthesiologist will help you decide whether to stop breastfeeding or avoid treatment with sugammadex, considering the benefit of breastfeeding for the baby and the benefit of sugammadex for the mother.

Driving and operating machines

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

Sugammadex Dr. Reddys contains sodium

This medication contains up to 9.7 mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 0.5% of the maximum daily sodium intake recommended for an adult.

Sugammadex will be administered by your anesthesiologist, or under the supervision of your anesthesiologist.

Dose

Your anesthesiologist will calculate the dose of sugammadex needed based on:

• your weight
• the amount of muscle relaxant still in effect.

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

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

How Sugammadex Dr. Reddys is Administered

Sugammadex will be administered by your anesthesiologist. It is given once by intravenous injection.

If You Receive More Sugammadex Dr. Reddys Than Recommended

As your anesthesiologist will be closely monitoring the situation, it is unlikely that too much sugammadex will be administered. However, even if this occurs, it is unlikely to cause any problems.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Frequent (may affect up to 1 in 10 people)

• Cough
• Difficulty with breathing that may include coughing or movements as if you are awake or taking a breath
• Superficial anesthesia – you may start to wake up, so you will need more anesthetic. This may cause you to move or cough at the end of the procedure
• Complications during the procedure, such as changes in heart rate, coughing, or movement
• Decrease in blood pressure due to the surgical intervention

Less frequent (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 medications) - such as rash, skin redness, swelling of your tongue and/or throat, difficult breathing, changes in blood pressure or heart rate, which sometimes results in a severe decrease in blood pressure. Severe allergic reactions or anaphylaxis can be life-threatening

Allergic reactions were reported more frequently in healthy, conscious volunteers

• Reappearance of muscle relaxation after the operation

Unknown frequency

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your anesthesiologist, another doctor, or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Storage will be handled by healthcare professionals.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the label after “CAD”. The expiration date is the last day of the month indicated.

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

Once opened and diluted, store at 2-8°C and use within 24 hours.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. These measures will help protect the environment.

Composition of Sugammadex Dr. Reddys

• The active ingredient is sugammadex.

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

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

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

The other components are injectable preparation water and pH adjustment: 0.04% sodium hydroxide and 0.3% hydrochloric acid.

Appearance of the product and contents of the package

Sugammadex Dr. Reddys is a transparent, colorless to slightly yellowish injectable solution.

Package sizes:

1 vial of 2 ml

10 vials of 2 ml

1 vial of 5 ml

10 vials of 5 ml

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona (Spain)

Phone: 93.355.49.16

Fax: 93.355.49.61

Responsible for manufacturing

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg,

Germany

or

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

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

Sector 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 with the following names:

Date of the last review of this prospect: August 2023

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